Coronary Artery DiseasePhase 3NCT00180453
SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System
A Phase 3 study testing Coronary artery drug eluting stent placement and Coronary artery stent placement in people with Coronary Artery Disease and Everolimus, run by Abbott Medical Devices at 7 sites in 3 countries.
Trial summary
Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial. Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter: 3.0mm) Control arm: Metallic stent (MULTI-LINK VISION® metallic stent(stent length: 18mm, diameter: 3.0mm) Follow-up angiographic imaging… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Everolimus, Vascular Disease
- What is being tested?
- Coronary artery drug eluting stent placement and Coronary artery stent placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Dec 2003to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patient must be at least 18 years of age.
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives of receiving the XIENCE™ V Everolimus Eluting Coronary Stent System and his or her legally authorized representative provides written informed consent prior to the stent procedure, as approved by the appropriate Ethics Committee.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Patient must agree to undergo all protocol-required follow-up examinations including angiographic and IVUS follow-up at two time points (180 days and 1 year ).
- Female patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
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- Female patients of childbearing potential must also agree at time of consent to use birth control up to and including the second angiographic follow-up at 1 year.
- Planned single, de novo, type A - B1, native coronary artery lesion treatment.
- Target lesion must be located in a native vessel with a diameter of 3.0 mm assessed by QCA on-line.
- Target lesion length ≤ 12 mm, assessed by QCA on-line.
- The target lesion must be in a major artery or branch with a stenosis of ≥ 50% and < 100% assessed by QCA on-line and with a TIMI flow of ≥ 1.
Who cannot join
- Patient has had a known acute myocardial infarction (greater than two times the upper limit of normal CK with presence of CK-MB) within 3 days preceding the index procedure and CK has not returned to normal limits at the time of the procedure.
- Patient has current or a history of unstable arrhythmias, regardless of whether cardiac rhythm management devices are used (e.g., pacemaker, Automatic Implantable Cardioverter Defibrillator).
- Patient has a known left ventricular ejection fraction ≥ 30%.
- Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
- Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
- Patient is receiving immunosuppression therapy or has known immunosuppressive disease.
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- Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
- Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, cobalt, chromium, nickel, tungsten, everolimus, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
- Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, patient on dialysis).
- Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Patient has had a cerebrovascular accident (CVA) or stroke or transient ischemic neurological attack (TIA) within the past six months.
- Patient has had a significant GI or urinary bleed within the past six months.
- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme anticoagulation.
- Patient has other medical illness (e.g., cancer or congestive heart failure) or recent history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Patient is already participating in another investigational use device or drug study or has completed the follow-up phase of another trial within the last 30 days.
- Patient has received a drug eluting stent within the last 1 year.
- The target lesion meets any of the following criteria:
- Aorto-ostial location
- Unprotected left main location
- Located within 2 mm of the origin of the LAD or LCX
- Located within or distal to an arterial or saphenous vein graft
- Located within 2 mm of a bifurcation
- Located distal to a previously implanted stent (same major epicardial vessel)
- 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 any type of PCI (e.g., POBA, stent, cutting balloon, atherectomy), except if previous treatment occurred in a side branch distal to target lesion at least 180 days preceding the index procedure
- Involves jailing of side branches > 2.0 mm in diameter
- Total occlusion (TIMI flow 0)
- Excessive tortuosity proximal to or within the lesion
- Extreme angulation (≥ 90%) proximal to or within the lesion
- Moderate to heavy calcification
- Restenotic from previous intervention
- The target vessel contains thrombus.
- Another significant lesion (≥ 40 %DS) is located in the same major epicardial vessel as the target lesion.
- Patient has a high probability that a procedure other than pre-dilatation and stenting will be required for treatment of the target vessel (e.g. atherectomy, cutting balloon).
- Patient has additional lesion(s) for which an intervention within 180 days (prior to or after) of the index procedure would be required or has been performed.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany4 sites
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
Kerckhoff-Klinik
Bad Nauheim, 61231
Herzzentrum Bad Oeynhausen
Bad Oeynhausen, 32545
Herzzentrum Siegburg GmbH
Siegburg
Netherlands2 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Erasmus Medical Center
Rotterdam
About this study
Official title: SPIRIT First: A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial.
Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter: 3.0mm) Control arm: Metallic stent (MULTI-LINK VISION® metallic stent(stent length: 18mm, diameter: 3.0mm) Follow-up angiographic imaging and intra vascular ultra sound (IVUS) at 180 days and 1 year
Read the detailed description
The SPIRIT FIRST clinical trial will enroll approximately 60 patients and will assess the feasibility and performance of the XIENCE V® Everolimus Eluting Coronary Stent System in the treatment of patients with de novo native coronary artery lesions. In this trial, the XIENCE V® Everolimus Eluting Coronary Stent System will be compared to the MULTI-LINK VISION® metallic stent which is CE marked and FDA approved and is available for commercial use in Europe and in the United States. The SPIRIT FIRST Clinical trial will enroll approximately 60 patients (30 patients in the test arm and 30 patients in the control arm) with de novo native coronary artery lesions in 4 clinical sites in The Netherlands and Germany
- Conditions
- Coronary Artery Disease, Everolimus, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Being tested
- Coronary artery drug eluting stent placement, Coronary artery stent placement
- Keywords
- Cardiovascular disease, Ischemia
- Medical subject headings
- Coronary Artery Disease, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis, Cardiovascular Diseases, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery drug eluting stent placementDevice
Coronary artery drug eluting stent placement
Coronary artery stent placementDevice
Also called Abbott Vascular MULTI-LINK VISION® coronary stent system
Coronary artery stent placement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System Receives: Device: Coronary artery drug eluting stent placement |
| 2 | Active comparator | Abbott Vascular MULTI-LINK VISION® BMS Receives: Device: Coronary artery stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late loss
Measured: at 180 days post procedure
Secondary outcomes (9)
In-stent late loss
Measured: at 1 year post procedure
In-segment Late Loss
Measured: at 180 days and 1 year
In-stent and in-segment %Volume Obstruction
Measured: at 180 days and 1 year
In-stent and in-segment %Diameter Stenosis
Measured: at 180 days and 1 year
In-stent and in-segment Angiographic Binary Restenosis rate
Measured: at 180 days and 1 year
Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection
Measured: at 180 days and 1 year
Major Adverse Cardiac Events
Measured: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years
Target Vessel Failure
Measured: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years
Acute success (device, procedure and clinical)
Measured: Acute
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 startDec 2003
- Primary completionApr 2005
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patrick Serruys, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180453
- Sponsor's protocol ID
- 02-350
- Status last verified
- Jun 2009
- First submitted
- 13 Sep 2005
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsuchida K, Garcia-Garcia HM, Ong AT, Valgimigli M, Aoki J, Rademaker TA, Morel MA, van Es GA, Bruining N, Serruys PW. Revisiting late loss and neointimal volumetric measurements in a drug-eluting stent trial: analysis from the SPIRIT FIRST trial. Catheter Cardiovasc Interv. 2006 Feb;67(2):188-97. doi: 10.1002/ccd.20581.
PubMed 16400664Popma JJ, Tulli M. Spirit First - Another hurdle is cleared. EuroIntervention. 2005 Nov;1(3):260-3. No abstract available.
PubMed 19758913Serruys PW, Ong AT, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher A, Grube E, Haase J, Thuesen L, Hamm C, Otto-Terlouw PC. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial. EuroIntervention. 2005 May;1(1):58-65.
PubMed 19758878Tsuchida K, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher AM, Grube E, Haase J, Thuesen L, Hamm CW, Veldhof S, Dorange C, Serruys PW. One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (The SPIRIT FIRST Trial). EuroIntervention. 2005 Nov;1(3):266-72.
PubMed 19758915SPRITI FIRST: 2-Jahres-ergebnisse. A durable polymer everolimus-eluting stent in de novo coronary narrowings. Richartz B.; Silber S. Herz ( Germany ) June 1, 2006 , 31/4 (359). ISSN: 0340-9937. Language: German
Muramatsu 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 24746650
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIRIT First: A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00180453
- Acronym / sponsor ID
- 02-350
- Conditions
- Coronary Artery Disease, Everolimus, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Keywords
- Cardiovascular disease, Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial.
Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter: 3.0mm) Control arm: Metallic stent (MULTI-LINK VISION® metallic stent(stent length: 18mm, diameter: 3.0mm) Follow-up angiographic imaging and intra vascular ultra sound (IVUS) at 180 days and 1 year
Detailed description
The SPIRIT FIRST clinical trial will enroll approximately 60 patients and will assess the feasibility and performance of the XIENCE V® Everolimus Eluting Coronary Stent System in the treatment of patients with de novo native coronary artery lesions. In this trial, the XIENCE V® Everolimus Eluting Coronary Stent System will be compared to the MULTI-LINK VISION® metallic stent which is CE marked and FDA approved and is available for commercial use in Europe and in the United States. The SPIRIT FIRST Clinical trial will enroll approximately 60 patients (30 patients in the test arm and 30 patients in the control arm) with de novo native coronary artery lesions in 4 clinical sites in The Netherlands and Germany
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: Coronary artery drug eluting stent placementAbbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System |
| 2 | Active comparator | Device: Coronary artery stent placementAbbott Vascular MULTI-LINK VISION® BMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient must be at least 18 years of age.
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives of receiving the XIENCE™ V Everolimus Eluting Coronary Stent System and his or her legally authorized representative provides written informed consent prior to the stent procedure, as approved by the appropriate Ethics Committee.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Patient must agree to undergo all protocol-required follow-up examinations including angiographic and IVUS follow-up at two time points (180 days and 1 year ).
Key exclusion criteria (36 listed)
- Patient has had a known acute myocardial infarction (greater than two times the upper limit of normal CK with presence of CK-MB) within 3 days preceding the index procedure and CK has not returned to normal limits at the time of the procedure.
- Patient has current or a history of unstable arrhythmias, regardless of whether cardiac rhythm management devices are used (e.g., pacemaker, Automatic Implantable Cardioverter Defibrillator).
- Patient has a known left ventricular ejection fraction ≥ 30%.
- Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
- Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
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 |
|---|---|---|
| Coronary artery drug eluting stent placementCoronary artery drug eluting stent placement | Device | 1 |
| Coronary artery stent placementAlso: Abbott Vascular MULTI-LINK VISION® coronary stent systemCoronary artery stent placement | Device | 2 |
Primary outcome
In-stent late loss
Time frame: at 180 days post procedure
9 secondary outcomes
In-stent late loss
Time frame: at 1 year post procedure
In-segment Late Loss
Time frame: at 180 days and 1 year
In-stent and in-segment %Volume Obstruction
Time frame: at 180 days and 1 year
In-stent and in-segment %Diameter Stenosis
Time frame: at 180 days and 1 year
In-stent and in-segment Angiographic Binary Restenosis rate
Time frame: at 180 days and 1 year
Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection
Time frame: at 180 days and 1 year
Major Adverse Cardiac Events
Time frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years
Target Vessel Failure
Time frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years
Acute success (device, procedure and clinical)
Time frame: Acute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
- Background: PubMed 16400664Tsuchida K, Garcia-Garcia HM, Ong AT, Valgimigli M, Aoki J, Rademaker TA, Morel MA, van Es GA, Bruining N, Serruys PW. Revisiting late loss and neointimal volumetric measurements in a drug-eluting stent trial: analysis from the SPIRIT FIRST trial. Catheter Cardiovasc Interv. 2006 Feb;67(2):188-97. doi: 10.1002/ccd.20581.
- Results publication: PubMed 19758913Popma JJ, Tulli M. Spirit First - Another hurdle is cleared. EuroIntervention. 2005 Nov;1(3):260-3. No abstract available.
- Results publication: PubMed 19758878Serruys PW, Ong AT, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher A, Grube E, Haase J, Thuesen L, Hamm C, Otto-Terlouw PC. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial. EuroIntervention. 2005 May;1(1):58-65.
- Results publication: PubMed 19758915Tsuchida K, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher AM, Grube E, Haase J, Thuesen L, Hamm CW, Veldhof S, Dorange C, Serruys PW. One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (The SPIRIT FIRST Trial). EuroIntervention. 2005 Nov;1(3):266-72.
- Results publicationSPRITI FIRST: 2-Jahres-ergebnisse. A durable polymer everolimus-eluting stent in de novo coronary narrowings. Richartz B.; Silber S. Herz ( Germany ) June 1, 2006 , 31/4 (359). ISSN: 0340-9937. Language: German
- 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.
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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.
Patrick Serruys, MD principal investigator
Erasmus Medical Center
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coronary artery drug eluting stent placement and Coronary artery stent placement in people with Coronary Artery Disease and Everolimus, run by Abbott Medical Devices at 7 sites in 3 countries.
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 11 inclusion and 36 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 6 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Netherlands, Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-stent late loss (time frame: at 180 days post procedure). 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 NCT00180453, which also lists 6 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 6 Jan 2010; AzTrials last refreshed its copy on 8 Nov 2026.