StentsPhase 3NCT00180479
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
A Phase 3 study testing XIENCE V® Everolimus Eluting Coronary Stent and TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent in people with Stents and Coronary Artery Disease, run by Abbott Medical Devices at 65 sites in United States.
Trial summary
This study is divided into 5 arms: 1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stents, Coronary Artery Disease, Total Coronary Occlusion
- What is being tested?
- XIENCE V® Everolimus Eluting Coronary Stent and TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,002 participants
- Where
- 65 sitesUnited States
- Study dates
- Jun 2005to Nov 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm
- The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of >= 1
- Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)
Who cannot join
- Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation
- Located in a major epicardial vessel that has been previously treated with brachytherapy
- Located in a major epicardial vessel that has been previously treated with percutaneous intervention < 9 months prior to index procedure
- Total occlusion (TIMI flow 0), prior to wire passing
- The target vessel contains thrombus
- Another significant lesion (> 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
Presbyterian Hospital
Albuquerque, New Mexico, 28204
Emory Crawford Long Hospital
Atlanta, Georgia, 30308
Piedmont Hospital
Atlanta, Georgia, 30309
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
Heart Hospital of Austin
Austin, Texas, 78756
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Baptist Medical Center Princeton
Birmingham, Alabama, 35211
Baptist Health System - Montclair
Birmingham, Alabama, 35213
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Fletcher Allen Health Care
Burlington, Vermont, 05401
Medical University of South Carolina
Charleston, South Carolina, 29403
Presbyterian Hospital
Charlotte, North Carolina, 87106
Rush University Medical Center
Chicago, Illinois, 60612
The Christ Hospital
Cincinnati, Ohio, 45219
Riverside Methodist Hospital
Columbus, Ohio, 43214
Medical City Dallas Hospital
Dallas, Texas, 75230
St John Hospital & Medical Center
Detroit, Michigan, 48236
Duke University Medical Center
Durham, North Carolina, 27710
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60148
EMH Regional Medical Center
Elyria, Ohio, 44035
Sacred Heart Medical Center
Eugene, Oregon, 97401
Poudre Valley Hospital
Fort Collins, Colorado, 80528
Holy Cross Medical Center (prev. North Ridge MC)
Fort Lauderdale, Florida, 33308
Spectrum Health Hospital
Grand Rapids, Michigan, 49503
Hackensack Medical Center
Hackensack, New Jersey, 07601
Pinnacle Health @ Harrisburg Hospital
Harrisburg, Pennsylvania, 17043
Methodist Hospital
Houston, Texas, 77030
The Heart Center of IN, LLC
Indianapolis, Indiana, 46290
Borgess Medical Center
Kalamazoo, Michigan, 49048
St. Luke's Hospital
Kansas City, Missouri, 64111
Scripps Memorial Hospital
La Jolla, California, 92037
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Nebraska Heart Hospital
Lincoln, Nebraska, 68526
Good Samaritan Hospital
Los Angeles, California, 87106
Jewish Hospital
Louisville, Kentucky, 40202
Baptist Hospital of Miami
Miami, Florida, 33176
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
St. Patrick Hospital
Missoula, Montana, 59802
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Columbia University Medical Center
New York, New York, 10032
Alta Bates Summit Medical Center
Oakland, California, 94609
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Integris Baptist Medical, Inc.
Oklahoma City, Oklahoma, 73112
Northern Michigan Hospital
Petoskey, Michigan, 49770
Arizona Heart Hospital
Phoenix, Arizona, 85016
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
Wake Medical Center
Raleigh, North Carolina, 27610
The Valley Hospital
Ridgewood, New Jersey, 07450
Mercy General Hospital
Sacramento, California, 95819
TexSan Heart Hospital
San Antonio, Texas, 78215
Swedish Medical Center
Seattle, Washington, 98104
St. John's Hospital
Springfield, Illinois, 62701
Barnes Jewish Hospital
St Louis, Missouri, 63110
St. Joseph's Hospital Health Center
Syracuse, New York, 13203
Washington Adventist Hospital
Takoma Park, Maryland, 20912
St. Joseph Medical Center
Towson, Maryland, 21204
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
This study is divided into 5 arms:
- Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System
- US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
- US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
- US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
- Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan
The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.
Read the detailed description
The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS (XIENCE V® arm) will be compared to an active control group represented by the FDA approved commercially available Boston Scientific TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System (TAXUS® arm).
The SPIRIT III clinical trial consists of a randomized clinical trial (RCT) in the US which will enroll approximately 1,002 subjects (2:1 randomization XIENCE V® EECS : TAXUS® EXPRESS2™ PECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 3.75 mm.
The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms (2.25 mm diameter stent, 4.0 mm diameter stent and 38 mm length stent arms) and one Japanese non-randomized arm as follows:
- 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 2.25 mm and < 2.5 mm and lesion length <= 22 mm will be enrolled concurrently in the US 2.25 mm non-randomized treatment arm
- 80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.75 mm and >= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the US 4.0 mm non-randomized treatment arm
- 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.0 mm and < 4.25 mm and lesion length > 24 mm and < 32 mm will be enrolled concurrently in the US 38 mm non-randomized treatment arm.
- 88 Japanese subjects with a maximum of two de novo native coronary artery lesions within vessel sizes >= 2.5 mm and <= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the non-randomized Japanese arm.
All subjects in the RCT and the four non-randomized arms will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the TAXUS® arm of US RCT.
Subjects enrolled in the US RCT will be sub-grouped based on whether they will have an angiographic and/or an intravascular ultrasound (IVUS) follow-up at 240 days as follows:
Group A: Angiographic and IVUS follow-up at 240 days (N=240) Group B: Angiographic follow-up at 240 days (N=324) Group C: No angiographic or IVUS follow-up (N=438)
All subjects will have clinical follow-up at 30, 180, 240 and 270 days (Data collected through 270 days will be submitted as the primary data set for US and Japanese market approval), and 1, 2, 3, 4, and 5 years (for annual reports).
All subjects enrolled into three US non-randomized arms (N=105 for 2.25 mm arm, N=80 for 4.0 mm arm and N=105 for 38 mm stent arm) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic follow-up at 240 days. No IVUS follow-up is required for subjects enrolled in these arms.
All subjects enrolled into the Japanese non-randomized arm (N=88) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic and IVUS follow-up at 240 days.
All subjects who receive a bailout stent will be assigned to Group A follow-up subgroup (angiographic and IVUS follow-up at 240 days after the index procedure), regardless of their primary assignment at randomization. At sites without IVUS capability, subjects receiving bailout stent will be assigned to Group B follow-up subgroup (angiographic follow-up at 240 days after the index procedure). Angiographic follow-up is required for all bailout subjects at 240 days.
Data from the US RCT will be submitted to the FDA as the primary data set for product approval for RVD >= 2.5 mm and <= 3.75 mm (2.5 mm, 3.0 mm and 3.5 mm stents). Combined data of the US trial/Japanese non-randomized arm will be submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Japanese approval for RVD>=2.5 mm and <= 4.25 mm (2.5 mm, 3.0 mm 3.5 mm and 4.0 mm stents). Data from the Japanese non-randomized arm will be submitted to the FDA as additional safety data. Data from the US non-randomized arms of the trial will be the primary data sets for approval for 2.25 mm diameter stent (RVD > 2.25 mm and < 2.5 mm), 4.0 mm diameter stent (RVD > 3.75 mm and <= 4.25 mm) and 38 mm length stent (RVD > 3.0 mm and <= 4.25 mm and lesion length > 24 mm and <= 32 mm), respectively in the US.
A pharmacokinetic substudy will be carried out in a minimum of 5 pre-determined sites in the US and a minimum of 5 pre-determined sites in Japan. In the US, the pharmacokinetics (PK) of everolimus, as delivered by the XIENCE V® EECS will be analyzed in a subset of 15 subjects (minimum) with single vessel/lesion treatment, and up to 20 subjects with dual vessel/lesion treatment, respectively. In Japan, a minimum of 10 subjects with single vessel/lesion treatment and up to 20 subjects with dual vessel/lesion treatment will have a PK measurements performed. These subsets will include subjects receiving overlapping stents.
- Conditions
- Stents, Coronary Artery Disease, Total Coronary Occlusion, Coronary Artery Restenosis, Stent Thrombosis, Vascular Disease
- Being tested
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Keywords
- Everolimus
- Medical subject headings
- Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE V® Everolimus Eluting Coronary StentDevice
Also called XIENCE V® Everolimus Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease.
TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary StentDevice
Also called TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | XIENCE V® Everolimus Eluting Coronary Stent System Receives: Device: XIENCE V® Everolimus Eluting Coronary Stent |
| 2 | Active comparator | TAXUS® EXPRESS2™Paclitaxel Eluting Coronary Stent System Receives: Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: In-segment Late Loss (LL)
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.
Measured: 240 days
Secondary outcomes (43)
Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)
The composite endpoint comprised of:
- Cardiac death (death in which a cardiac cause cannot be excluded)
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
- Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Measured: 270 days
Target Vessel Failure (TVF)
The composite endpoint comprised of:
- Cardiac death (death in which a cardiac cause cannot be excluded)
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
- Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Measured: 30 days
Target Vessel Failure (TVF)
The composite endpoint comprised of:
- Cardiac death (death in which a cardiac cause cannot be excluded)
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
- Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Measured: 180 days
Target Vessel Failure (TVF)
The composite endpoint comprised of:
- Cardiac death (death in which a cardiac cause cannot be excluded)
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
- Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Measured: 1 year
Target Vessel Failure (TVF)
The composite endpoint comprised of:
- Cardiac death (death in which a cardiac cause cannot be excluded)
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
- Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Measured: 2 year
Target Vessel Failure (TVF)
The composite endpoint comprised of:
- Cardiac death (death in which a cardiac cause cannot be excluded)
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
- Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Measured: 3 year
Target Vessel Failure (TVF)
The composite endpoint comprised of:
- Cardiac death (death in which a cardiac cause cannot be excluded)
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
- Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Measured: 4 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Measured: 30 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Measured: 180 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Measured: 270 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Measured: 1 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Measured: 2 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Measured: 3 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Measured: 4 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization at the target vessel associated with any of the following
- Positive functional ischemia study
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
Measured: 30 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization at the target vessel associated with any of the following
- Positive functional ischemia study
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
Measured: 180 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization at the target vessel associated with any of the following
- Positive functional ischemia study
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
Measured: 270 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization at the target vessel associated with any of the following
- Positive functional ischemia study
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
Measured: 1 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization at the target vessel associated with any of the following
- Positive functional ischemia study
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
Measured: 2 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization at the target vessel associated with any of the following
- Positive functional ischemia study
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
Measured: 3 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization at the target vessel associated with any of the following
- Positive functional ischemia study
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
Measured: 4 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
The composite endpoint comprised of:
- Cardiac death
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Measured: 30 days
Ischemia Driven Major Adverse Cardiac Event (MACE)
The composite endpoint comprised of:
- Cardiac death
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Measured: 180 days
Ischemia Driven Major Adverse Cardiac Event (MACE)
The composite endpoint comprised of:
- Cardiac death
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Measured: 270 days
Ischemia Driven Major Adverse Cardiac Event (MACE)
The composite endpoint comprised of:
- Cardiac death
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Measured: 1 year
Ischemia Driven Major Adverse Cardiac Event(MACE)
The composite endpoint comprised of:
- Cardiac death
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Measured: 2 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
The composite endpoint comprised of:
- Cardiac death
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Measured: 3 year
Ischemia Driven Major Adverse Cardiac Event (MACE)
The composite endpoint comprised of:
- Cardiac death
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Measured: 4 year
In-stent % Angiographic Binary Restenosis (% ABR) Rate
Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
Measured: at 240 days
In-segment % Angiographic Binary Restenosis (% ABR) Rate
Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA
Measured: 240 days
Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection
Incomplete Apposition (Persisting \& Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol \& ARC definition.
Persisting dissection @ follow-up, present post-procedure.
Measured: at 240 days
Acute Success: Clinical Device
Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.
Measured: In-hospital
Acute Success: Clinical Procedure
Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.
Measured: In-hospital
Proximal Late Loss
Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)
Measured: at 240 days
Distal Late Loss
Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)
Measured: 240 days
In-stent Late Loss
In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)
Measured: at 240 days
% Volume Obstruction (% VO)
Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.
Measured: at 240 days
In-stent % Diameter Stenosis (% DS)
In-stent: Within the margins of the stent, the value calculated as 100 * (1 - in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Measured: at 240 days
In-segment % Diameter Stenosis (% DS)
Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 - in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Measured: 240 days
Target Vessel Failure (TVF)
The composite endpoint comprised of:
- Cardiac death (death in which a cardiac cause cannot be excluded)
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
- Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
Measured: 5 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization @ target lesion associated w/ any of following:
(+) functional ischemia study Ischemic symptoms \& angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
Measured: 5 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization at the target vessel associated with any of the following
- Positive functional ischemia study
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Derived from Non-Hierarchical Subject Counts of Adverse Events
Measured: 5 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
The composite endpoint comprised of:
- Cardiac death
- Myocardial infarction (MI, classified as Q-wave and non-Q wave)
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2006
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StentsStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg W Stone, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180479
- Sponsor's protocol ID
- 03-360
- Status last verified
- Nov 2011
- First submitted
- 13 Sep 2005
- Last updated
- 23 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
PubMed 18430909Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial. Circulation. 2009 Feb 10;119(5):680-6. doi: 10.1161/CIRCULATIONAHA.108.803528. Epub 2009 Jan 26.
PubMed 19171853Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):719-27. doi: 10.1002/ccd.22067.
PubMed 19530147Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.
PubMed 25940520Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
PubMed 24746650Claessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovasc Interv. 2011 Nov;4(11):1209-15. doi: 10.1016/j.jcin.2011.07.016.
PubMed 22115661Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15. doi: 10.1016/j.jcin.2011.06.018.
PubMed 22017936Kereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW. Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1229-39. doi: 10.1016/j.jcin.2010.09.014.
PubMed 21232716Caixeta A, Lansky AJ, Serruys PW, Hermiller JB, Ruygrok P, Onuma Y, Gordon P, Yaqub M, Miquel-Hebert K, Veldhof S, Sood P, Su X, Jonnavithula L, Sudhir K, Stone GW; SPIRIT II and III Investigators. Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents: a pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1220-8. doi: 10.1016/j.jcin.2010.07.017.
PubMed 21232715
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00180479
- Acronym / sponsor ID
- 03-360
- Conditions
- Stents, Coronary Artery Disease, Total Coronary Occlusion, Coronary Artery Restenosis, Stent Thrombosis, Vascular Disease
- Keywords
- Everolimus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 15 Dec 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is divided into 5 arms:
- Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System
- US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
- US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
- US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
- Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan
The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.
Detailed description
The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS (XIENCE V® arm) will be compared to an active control group represented by the FDA approved commercially available Boston Scientific TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System (TAXUS® arm).
The SPIRIT III clinical trial consists of a randomized clinical trial (RCT) in the US which will enroll approximately 1,002 subjects (2:1 randomization XIENCE V® EECS : TAXUS® EXPRESS2™ PECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 3.75 mm.
The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms (2.25 mm diameter stent, 4.0 mm diameter stent and 38 mm length stent arms) and one Japanese non-randomized arm as follows:
- 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 2.25 mm and < 2.5 mm and lesion length <= 22 mm will be enrolled concurrently in the US 2.25 mm non-randomized treatment arm
- 80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.75 mm and >= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the US 4.0 mm non-randomized treatment arm
- 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.0 mm and < 4.25 mm and lesion length > 24 mm and < 32 mm will be enrolled concurrently in the US 38 mm non-randomized treatment arm.
- 88 Japanese subjects with a maximum of two de novo native coronary artery lesions within vessel sizes >= 2.5 mm and <= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the non-randomized Japanese arm.
All subjects in the RCT and the four non-randomized arms will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the TAXUS® arm of US RCT.
Subjects enrolled in the US RCT will be sub-grouped based on whether they will have an angiographic and/or an intravascular ultrasound (IVUS) follow-up at 240 days as follows:
Group A: Angiographic and IVUS follow-up at 240 days (N=240) Group B: Angiographic follow-up at 240 days (N=324) Group C: No angiographic or IVUS follow-up (N=438)
All subjects will have clinical follow-up at 30, 180, 240 and 270 days (Data collected through 270 days will be submitted as the primary data set for US and Japanese market approval), and 1, 2, 3, 4, and 5 years (for annual reports).
All subjects enrolled into three US non-randomized arms (N=105 for 2.25 mm arm, N=80 for 4.0 mm arm and N=105 for 38 mm stent arm) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic follow-up at 240 days. No IVUS follow-up is required for subjects enrolled in these arms.
All subjects enrolled into the Japanese non-randomized arm (N=88) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic and IVUS follow-up at 240 days.
All subjects who receive a bailout stent will be assigned to Group A follow-up subgroup (angiographic and IVUS follow-up at 240 days after the index procedure), regardless of their primary assignment at randomization. At sites without IVUS capability, subjects receiving bailout stent will be assigned to Group B follow-up subgroup (angiographic follow-up at 240 days after the index procedure). Angiographic follow-up is required for all bailout subjects at 240 days.
Data from the US RCT will be submitted to the FDA as the primary data set for product approval for RVD >= 2.5 mm and <= 3.75 mm (2.5 mm, 3.0 mm and 3.5 mm stents). Combined data of the US trial/Japanese non-randomized arm will be submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Japanese approval for RVD>=2.5 mm and <= 4.25 mm (2.5 mm, 3.0 mm 3.5 mm and 4.0 mm stents). Data from the Japanese non-randomized arm will be submitted to the FDA as additional safety data. Data from the US non-randomized arms of the trial will be the primary data sets for approval for 2.25 mm diameter stent (RVD > 2.25 mm and < 2.5 mm), 4.0 mm diameter stent (RVD > 3.75 mm and <= 4.25 mm) and 38 mm length stent (RVD > 3.0 mm and <= 4.25 mm and lesion length > 24 mm and <= 32 mm), respectively in the US.
A pharmacokinetic substudy will be carried out in a minimum of 5 pre-determined sites in the US and a minimum of 5 pre-determined sites in Japan. In the US, the pharmacokinetics (PK) of everolimus, as delivered by the XIENCE V® EECS will be analyzed in a subset of 15 subjects (minimum) with single vessel/lesion treatment, and up to 20 subjects with dual vessel/lesion treatment, respectively. In Japan, a minimum of 10 subjects with single vessel/lesion treatment and up to 20 subjects with dual vessel/lesion treatment will have a PK measurements performed. These subsets will include subjects receiving overlapping stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: XIENCE V® Everolimus Eluting Coronary StentXIENCE V® Everolimus Eluting Coronary Stent System |
| 2 | Active comparator | Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary StentTAXUS® EXPRESS2™Paclitaxel Eluting Coronary Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm
- The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of >= 1
- Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)
Key exclusion criteria (7 listed)
- Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation
- Located in a major epicardial vessel that has been previously treated with brachytherapy
- Located in a major epicardial vessel that has been previously treated with percutaneous intervention < 9 months prior to index procedure
- Total occlusion (TIMI flow 0), prior to wire passing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XIENCE V® Everolimus Eluting Coronary StentAlso: XIENCE V® Everolimus Eluting Coronary Stent SystemDrug eluting stent implantation stent in the treatment of coronary artery disease. | Device | 1 |
| TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary StentAlso: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent SystemDrug eluting stent implantation stent in the treatment of coronary artery disease. | Device | 2 |
Primary outcome
Primary Endpoint: In-segment Late Loss (LL)
Time frame: 240 days
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.
43 secondary outcomes
Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)
Time frame: 270 days
Target Vessel Failure (TVF)
Time frame: 30 days
Target Vessel Failure (TVF)
Time frame: 180 days
Target Vessel Failure (TVF)
Time frame: 1 year
Target Vessel Failure (TVF)
Time frame: 2 year
Target Vessel Failure (TVF)
Time frame: 3 year
Target Vessel Failure (TVF)
Time frame: 4 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 30 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 180 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 270 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 1 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 2 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 3 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 4 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 30 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 180 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 270 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 1 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 2 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 3 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 4 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 30 days
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 180 days
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 270 days
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 1 year
Ischemia Driven Major Adverse Cardiac Event(MACE)
Time frame: 2 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 3 year
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time frame: 4 year
In-stent % Angiographic Binary Restenosis (% ABR) Rate
Time frame: at 240 days
In-segment % Angiographic Binary Restenosis (% ABR) Rate
Time frame: 240 days
Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection
Time frame: at 240 days
Acute Success: Clinical Device
Time frame: In-hospital
Acute Success: Clinical Procedure
Time frame: In-hospital
Proximal Late Loss
Time frame: at 240 days
Distal Late Loss
Time frame: 240 days
In-stent Late Loss
Time frame: at 240 days
% Volume Obstruction (% VO)
Time frame: at 240 days
In-stent % Diameter Stenosis (% DS)
Time frame: at 240 days
In-segment % Diameter Stenosis (% DS)
Time frame: 240 days
Target Vessel Failure (TVF)
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18430909Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
- Results publication: PubMed 19171853Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial. Circulation. 2009 Feb 10;119(5):680-6. doi: 10.1161/CIRCULATIONAHA.108.803528. Epub 2009 Jan 26.
- Results publication: PubMed 19530147Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: clinical and angiographic results from the SPIRIT III randomized trial. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):719-27. doi: 10.1002/ccd.22067.
- Derived from this study: PubMed 25940520Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.
- Derived from this study: PubMed 24746650Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
- Derived from this study: PubMed 22115661Claessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovasc Interv. 2011 Nov;4(11):1209-15. doi: 10.1016/j.jcin.2011.07.016.
- Derived from this study: PubMed 22017936Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15. doi: 10.1016/j.jcin.2011.06.018.
- Derived from this study: PubMed 21232716Kereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW. Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1229-39. doi: 10.1016/j.jcin.2010.09.014.
- Derived from this study: PubMed 21232715Caixeta A, Lansky AJ, Serruys PW, Hermiller JB, Ruygrok P, Onuma Y, Gordon P, Yaqub M, Miquel-Hebert K, Veldhof S, Sood P, Su X, Jonnavithula L, Sudhir K, Stone GW; SPIRIT II and III Investigators. Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents: a pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1220-8. doi: 10.1016/j.jcin.2010.07.017.
Related trials for Stents
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Recruiting
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Coronary Artery Disease
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg W Stone, MD principal investigator
Columbia University
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XIENCE V® Everolimus Eluting Coronary Stent and TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent in people with Stents and Coronary Artery Disease, run by Abbott Medical Devices at 65 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint: In-segment Late Loss (LL) (time frame: 240 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00180479, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2011.