Comparison of the Conor Sirolimus-eluting Coronary Stent to the Taxus Liberte Paclitaxel-eluting Coronary Stent in the Treatment of Coronary Artery Lesions

NCT00606333 | Terminated DMC

• 1 other identifier: CP-06
• Study Type: interventional
• Target: 394
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries. The study will evaluate the outcomes of a new drug-eluting stent compared to an approved drug-eluting stent. 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.

Conditions

Coronary Atherosclerosis

Keywords

Coronary artery disease; drug-eluting stents; sirolimus-eluting coronary stents

Outcome Measures

Primary Outcomes (1)

• Angiographic endpoint of in-stent late lumen loss as measured by QCA.

  6 months

Secondary Outcomes (12)

• Target Lesion Failure defined as cardiac death that cannot be clearly attributed to a non-cardiac event or non-target vessel, target vessel related myocardial infarction or clinically driven target lesion revascularization.

  hospital discharge, 30 days, 6 months and annually through five years.

• Target Vessel Failure defined as any myocardial infarction or cardiac death that cannot be attributed to a non-target vessel or any target vessel revascularization.

  Hospital discharge, 30 days, 6 months and annually through five years

• Major Adverse Cardiac Events defined as an adjudicated composite of death, emergent coronary artery bypass graft surgery, target lesion revascularization, or new myocardial infarction.

  Hospital discharge, 30 days, 6 months and annually through five years

• Incidence of stent thrombosis

  Hospital discharge, 30 days, 6 months and annually through five years

• Incidence of target lesion revascularization and target vessel revascularization.

  Hospital discharge, 30 days, 6 months and annually through five years

Study Arms (2)

Investigational arm

EXPERIMENTAL

Subjects randomized to treatment with the NEVO™ Sirolimus-eluting Coronary Stent System.

Device: NEVO™ Sirolimus-eluting Coronary Stent System

Control Arm

ACTIVE COMPARATOR

Subjects randomized to treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System.

Device: Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)

Interventions

NEVO™ Sirolimus-eluting Coronary Stent System DEVICE

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.

Investigational arm

Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System) DEVICE

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.

Also known as: Taxus Liberte Paclitaxel-eluting Coronary Stent System

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• 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.

You may not qualify if:

• The subject has undergone coronary revascularization to any vessel within 30 days.
• 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.

Sponsors & Collaborators

• Cordis US Corp.: lead
• Conor Medsystems: collaborator

Study Sites (2)

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012-909, Brazil

Location

Mercy Angiography Unit

Epsom, Auckland, New Zealand

Location

Related Publications (3)

• 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.

  PMID: 21062998 RESULT

• 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.

  PMID: 21386089 RESULT

• 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.

  PMID: 23518218 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• John Ormiston, MB ChM

  Mercy Angiography Unit

  PRINCIPAL INVESTIGATOR

• Alexandre Abizaid, MD. PhD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: February 1, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: October 1, 2012
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

BR (1); NZ (1)