Comparison of the Conor Sirolimus-eluting Coronary Stent to the Taxus Liberte Paclitaxel-eluting Coronary Stent in the Treatment of Coronary Artery Lesions
NCT ID: NCT00606333
Last Updated: 2012-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
394 participants
INTERVENTIONAL
2008-03-31
2012-10-31
Brief Summary
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While Cordis made a business decision to no longer pursue NEVO™ development and commercialization, the patients will be followed up as per protocol. This includes performing all protocol required follow-up visits and the collection and reporting of all safety information.
Detailed Description
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This study will evaluate a new sirolimus-eluting cobalt chromium coronary stent system compared to an approved paclitaxel-eluting coronary stent system in the treatment of single de novo coronary lesions in native coronary arteries. Subjects meeting qualification will be randomized in a 1:1 fashion to treatment with the Conor sirolimus-eluting coronary stent or to treatment with an approved paclitaxel-eluting coronary stent. All subjects will undergo angiographic follow-up at six months and complete clinical follow-up for a period of five years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Investigational arm
Subjects randomized to treatment with the NEVO™ Sirolimus-eluting Coronary Stent System.
NEVO™ Sirolimus-eluting Coronary Stent System
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the Conor Cobalt Chromium Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
Control Arm
Subjects randomized to treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System.
Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
Interventions
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NEVO™ Sirolimus-eluting Coronary Stent System
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the Conor Cobalt Chromium Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible for percutaneous coronary intervention and coronary artery bypass graft surgery.
* Diagnosis of stable or unstable angina or silent ischemia
* Left ventricular ejection fraction \>30%
* The subject requires treatment of a single de novo lesion in a native coronary artery.
* Lesion to be treated is less than or equal to 28 mm in length in a vessel that is 2.5-3.5mm diameter.
* The target lesion diameter stenosis is \>50% and \<100% by visual estimate.
* The target lesion is a minimum of 10 mm distance from any previously treated segment of the target vessel.
* The subject understands the study requirements, is willing to comply with all study procedures and has provided written informed consent.
Exclusion Criteria
* The subject has undergone target vessel revascularization within 6 months.
* Treatment of more than one qualifying lesion is required at the time of enrollment, or is planned within 30 days following enrollment.
* The subject has known sensitivity to sirolimus, paclitaxel, the polymeric matrices, stainless steel or cobalt chromium.
* There is planned treatment of the target lesion with any device other than the pre-dilatation balloon angioplasty catheter.
* The subject had a myocardial infarction within 72 hours, or presents with CK elevation \> 2 times upper limit normal associated with elevated CK-MB.
* The subject is in cardiogenic shock.
* The subject had a cerebrovascular accident within the past 6 months.
* The subject has acute or chronic renal dysfunction (defined as creatinine \>2.0 mg/dl).
* The subject has a contraindication to aspirin or clopidogrel.
* The subject has thrombocytopenia (platelet count \< 100,000/mm3.
* The subject has had active gastrointestinal bleeding within the past 3 months.
* The subject has a known bleeding or hypercoagulable disorder.
* The subject has had prior anaphylactoid reaction to contrast agents or has contrast sensitivity that cannot be controlled with pre-medication.
* The subject is currently taking immunosuppressant therapy.
* The subject is currently, or has been treated wtih either Rapamune or paclitaxel within 12 months of the procedure.
* The subject is a female with a positive pregnancy test or is lactating.
* The subject has an active infection.
* The subject has co-morbidities that could interfere wtih completion of study procedures, or life expectancy less than 24 months.
* The subject is participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.
* Left main disease \>50% diameter stenosis.
* The target lesion is ostial.
* The target lesion or target vessel are severely calcified.
* The target lesion involves a bifurcation with diseased branch vessel greater than or equal to 2.0 mm that would require intervention or protection.
* The target lesion has TIMI o or TIMI I flow.
* Angiographic evidence of thrombus.
* The target vessel has had prior stent placement.
* The patient has had prior coronary brachytherapy.
* There is angiographic restenosis of any previously treated segment of the target vessel, or atherosclerotic area wtih \>50% diameter stenosis outside of the target lesion.
* The subject has undergone prior CABG.
18 Years
ALL
No
Sponsors
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Conor Medsystems
INDUSTRY
Cordis Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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John Ormiston, MB ChM
Role: PRINCIPAL_INVESTIGATOR
Mercy Angiography Unit
Alexandre Abizaid, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Dante Pazzanese de Cardiologia
Locations
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Instituto Dante Pazzanese de Cardiologia
São Paulo, , Brazil
Mercy Angiography Unit
Epsom, Auckland, New Zealand
Countries
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References
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Ormiston JA, Abizaid A, Spertus J, Fajadet J, Mauri L, Schofer J, Verheye S, Dens J, Thuesen L, Dubois C, Hoffmann R, Wijns W, Fitzgerald PJ, Popma JJ, Macours N, Cebrian A, Stoll HP, Rogers C, Spaulding C; NEVO ResElution-I Investigators. Six-month results of the NEVO Res-Elution I (NEVO RES-I) trial: a randomized, multicenter comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberte paclitaxel-eluting stent in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2010 Dec;3(6):556-64. doi: 10.1161/CIRCINTERVENTIONS.110.946426. Epub 2010 Nov 9.
Otake H, Honda Y, Courtney BK, Shimohama T, Ako J, Waseda K, Macours N, Rogers C, Popma JJ, Abizaid A, Ormiston JA, Spaulding C, Cohen SA, Fitzgerald PJ. Intravascular ultrasound results from the NEVO ResElution-I trial: a randomized, blinded comparison of sirolimus-eluting NEVO stents with paclitaxel-eluting TAXUS Liberte stents in de novo native coronary artery lesions. Circ Cardiovasc Interv. 2011 Apr 1;4(2):146-54. doi: 10.1161/CIRCINTERVENTIONS.110.957175. Epub 2011 Mar 8.
Abizaid A, Ormiston JA, Fajadet J, Mauri L, Schofer J, Verheye S, Dens J, Thuesen L, Macours N, Qureshi AC, Spaulding C; NEVO ResElution-I Investigators. Two-year follow-up of the NEVO ResElution-I(NEVO RES-I) trial: a randomised, multicentre comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberte paclitaxel-eluting stent in de novo native coronary artery lesions. EuroIntervention. 2013 Oct;9(6):721-9. doi: 10.4244/EIJV9I6A116.
Other Identifiers
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CP-06
Identifier Type: -
Identifier Source: org_study_id