Coronary DiseasePhase 4SPIRIT VNCT00402272
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
A Phase 4 study testing XIENCE V® Everolimus Eluting Coronary Stent in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 93 sites in 23 countries.
Trial summary
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- XIENCE V® Everolimus Eluting Coronary Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,700 participants
- Where
- 93 sitesin 23 countries
- Study dates
- Nov 2006to Jun 2010
- Phase
- Phase 4
- 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
- at least 18 years
- able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
- evidence of myocardial ischemia
- acceptable candidate for coronary artery bypass graft (CABG) surgery
- undergo all CIP-required follow-up examinations
- artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC
Show all 9Show fewer
- target lesions must be de novo lesions
- target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
- target lesion ≤ 28 mm in length by visual estimate
Who cannot join
- Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
Trial locations and contacts
93 sites in 23 countries.
93 sites in 23 countries
Spain14 sites
Hospital del Mar
Barcelona
Hospital Santa Creu I Sant Pau
Barcelona
Hospital Universitari de Bellvigte
Barcelona
Trias Y Pujol
Barcelona
Valle Hebron
Barcelona
Puerta del Mar
Cadiz
Policlinica Gipuzkoa
Donostia / San Sebastian
Clinico San Carlos
Madrid
Hospital Puerta de Hierro
Madrid
La Paz
Madrid
Hospital Virgen de la Arrixaca
Murcia
Hospital Son Dureta
Palma de Mallorca
Marques de Valdecilla
Santander
Meixoeiro-Medtec
Vigo
Italy11 sites
Azienda USL 8
Arezzo
Azienda Ospedaliera Riuniti
Bergamo
Emodinamica Azienda Spedali Civili
Brescia
Azienda Ospedaliera G. Brotzu
Cagliari
Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1
Mestre
Ospedale Civile
Mirano
Azienda Ospedaliera di Padova
Padova
IRCCS Policlinico San Matteo
Pavia
Ospedale San Filippo Neri
Roma
Policlinico A. Gemelli
Roma
Azienda Ospedaliera S. Gdi Dio Salerno
Salerno
India8 sites
Krishna Heart Institute
Ahmedabad
Apollo Hospital
Chennai
Institute of Cardiovascular Disease M.M.M.
Chennai
All India Institute of Medical Science - AIIMS
Delhi
Fortis Hospital
Delhi
B M Birla
Kolkata
Kailash Hospital
New Delhi
Ruby Hall Clinic
Pune
Canada7 sites
Foothills Medical Center
Calgary
CHUM Hotel Dieu Hospital
Montreal
Montreal Heart Institute
Montreal
University of Ottawa Heart Institute
Ottawa
Hôpital Laval
Québec
Sunnybrook and Women's College
Toronto
University health Network - Toronto Gen Hospital
Toronto
France7 sites
C.H.U. - Hopital Michallon
Grenoble
CHU Lille - Hôpital Cardiologique
Lille
NCN - Nouvelle Cliniques Nantaises
Nantes
Hopital privé Les Fransiscaines
Nîmes
La pitié Salpétrière
Paris
Polyclinique St Laurent
Rennes
C.C.N.
Saint-Denis
Germany7 sites
Kerckhoff Klinik GmbH
Bad Nauheim
Herzzentrum
Bernau
Universitätsklinikum
Heidelberg
Lukas Krankenhaus Neuss
Neuss
Herzzentrum Siegburg GmbH
Siegburg, 53721
Universitätsklinikum Ulm
Ulm
Helios Klinikum Wuppertal
Wuppertal
Belgium5 sites
UCL St Luc
Brussels
ULB Erasmus Hospital
Brussels
UZ Gent
Ghent
Hopital St Joseph
Gilly
Clinique St. Luc - Bouge
Namur
China5 sites
Fuwai Hospital
Beijing
Prince of Wales Hospital
Hong Kong
PYNEH
Hong Kong
Queen Elizabeth
Hong Kong
Zhongshan Hospital
Shanghai
United Kingdom5 sites
Royal Sussex County, Brighton
Brighton
Glenfield Hospital
Leicester
King's College Hospital
London
Wythenshawe Hospital
Manchester
Wessex Cardiac Unit
Southampton, Southampton, SO16 6YD
Israel3 sites
Hadassah-Hebrew University Medical Center
Jerusalem
Sheba Medical Center
Ramat Gan
Ichilov Medical Center
Tel Aviv
Netherlands3 sites
Medisch Centrum Alkmaar
Alkmaar
Catharina ZH Eindhoven
Eindhoven
Maasstad Ziekenhuis
Rotterdam
Portugal3 sites
Hospital Garcia da Orta
Lisbon
Hospital Santa Cruz
Lisbon
Hospital Santa Marta
Lisbon
Malaysia2 sites
Institute Jantung Negara
Kuala Lumpur
Sarawak General Hospital
Kuching
South Africa2 sites
Sunninghill Hospital
Johannesburg
Vergelegen Clinic
Vergelegen
Thailand2 sites
Bhumibol Adulyadej Hospital
Bangkok
King Chulalongkorn Memorial Hospital
Bangkok
About this study
Official title: SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.
Read the detailed description
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry.
The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating performance of the XIENCE V® EECSS in real-world use, per its Instruction For Use (IFU). 2,700 patients will be enrolled in the SPIRIT V Registry.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Registry study after 2 years.
- Being tested
- XIENCE V® Everolimus Eluting Coronary Stent
- Keywords
- drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
- Medical subject headings
- Coronary Disease, 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | XIENCE V® Everolimus Eluting Coronary Stent System Receives: Device: XIENCE V® Everolimus Eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .
Measured: at 30 days
Secondary outcomes (7)
SPIRIT V Registry: Acute Success (Clinical Procedure Success)
Measured: Acute
SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)
Measured: at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)
Measured: at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR
Measured: at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR
Measured: at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)
Measured: at 30 days, 1 and 2 years
SPIRIT V Registry: Acute Success (Clinical Device Success)
Measured: Acute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionFeb 2008
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eberhard Grube, MD, Principal investigator, The Heart Center, Siegburg, GermanyUpendra Kaul, MD, Principal investigator, Fortis Hospital, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402272
- Sponsor's protocol ID
- 05-369
- Acronym
- SPIRIT V
- Status last verified
- Oct 2010
- First submitted
- 17 Nov 2006
- Last updated
- 14 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Genereux 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 25940520Ringel RE, Gauvreau K, Moses H, Jenkins KJ. Coarctation of the Aorta Stent Trial (COAST): study design and rationale. Am Heart J. 2012 Jul;164(1):7-13. doi: 10.1016/j.ahj.2012.04.008. Epub 2012 Jun 20.
PubMed 22795276Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.
PubMed 22607866
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00402272
- Acronym / sponsor ID
- SPIRIT V / 05-369
- Keywords
- drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,700 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Nov 2006 (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.
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.
Detailed description
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry.
The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating performance of the XIENCE V® EECSS in real-world use, per its Instruction For Use (IFU). 2,700 patients will be enrolled in the SPIRIT V Registry.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Registry study after 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: XIENCE V® Everolimus Eluting Coronary StentXIENCE V® Everolimus 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 (9 listed)
- at least 18 years
- able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
- evidence of myocardial ischemia
- acceptable candidate for coronary artery bypass graft (CABG) surgery
- undergo all CIP-required follow-up examinations
Key exclusion criteria (1 listed)
- Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
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 |
Primary outcome
SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .
Time frame: at 30 days
7 secondary outcomes
SPIRIT V Registry: Acute Success (Clinical Procedure Success)
Time frame: Acute
SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)
Time frame: at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)
Time frame: at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR
Time frame: at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR
Time frame: at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)
Time frame: at 30 days, 1 and 2 years
SPIRIT V Registry: Acute Success (Clinical Device Success)
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 14 Oct 2010.
- 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 22795276Ringel RE, Gauvreau K, Moses H, Jenkins KJ. Coarctation of the Aorta Stent Trial (COAST): study design and rationale. Am Heart J. 2012 Jul;164(1):7-13. doi: 10.1016/j.ahj.2012.04.008. Epub 2012 Jun 20.
- Derived from this study: PubMed 22607866Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Eberhard Grube, MD principal investigator
The Heart Center, Siegburg, Germany
Upendra Kaul, MD principal investigator
Fortis Hospital, New Delhi, India
93 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XIENCE V® Everolimus Eluting Coronary Stent in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 93 sites in 23 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 9 inclusion and 1 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 14 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in Spain, Italy, India, Canada, France and 18 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) . (time frame: at 30 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 NCT00402272, which also lists 3 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 14 Oct 2010.