A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems - Tabular View

Tracking Information

First Received Date ^ICMJE

May 4, 2006

Last Updated Date

November 10, 2009

Start Date ^ICMJE

July 2006

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary angiographic late loss in the stent at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Primary angiographic late loss in the stent at 6 months.

Change History

Complete list of historical versions of study NCT00322569 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

MACE defined as cardiac death, new MI, or TVR at 30 days and 6 months, 1, 2, 3, 4 and 5 years; Device, Lesion and Procedure Success; coronary angiography at 6 months; IVUS measurements in IVUS coh [ Time Frame: 30 days and 6 months, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

MACE defined as cardiac death, new MI, or TVR at 30 days and 6 months, 1, 2, 3, 4 and 5 years; Device, Lesion and Procedure Success; coronary angiography at 6 months; IVUS measurements in IVUS coh

Descriptive Information

Brief Title ^ICMJE

A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems

Official Title ^ICMJE

A Randomized, Multi-Center Study of the Pimecrolimus-Eluting (Corio™) and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System (SymBio™) in Patients With De Novo Lesions of the Native Coronary Arteries

Brief Summary

Randomized, three-arm, multi-center, clinical trial evaluating the Corio™ Pimecrolimus and SymBio™ Pimecrolimus/Paclitaxel-eluting stents compared to the CoStar™ in patients with de novo lesions of the native coronary arteries.

Detailed Description

This study is designed to evaluate 6 month in-stent late lumen loss of the 1) Corio™ pimecrolimus-eluting coronary stent system and the 2) SymBio™ dual pimecrolimus/paclitaxel-eluting coronary stent system compared to the CoStar™ Paclitaxel-Eluting Coronary Stent System control arm.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Coronary Disease

Intervention ^ICMJE

Device: Corio™ Pimecrolimus-eluting stent
Device: SymBio™ Pimecrolimus/Paclitaxel-eluting stent

Study Arms / Comparison Groups

Experimental: Pimecrolimus-ElutinG Cobalt Chromium Coronary Stent System
Experimental: SymBio™ Pimecrolimus/Paclitaxel-eluting stent

Publications *

Verheye S, Agostoni P, Dawkins KD, Dens J, Rutsch W, Carrie D, Schofer J, Lotan C, Dubois CL, Cohen SA, Fitzgerald PJ, Lansky AJ. The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) trial. JACC Cardiovasc Interv. 2009 Mar;2(3):205-14.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

246

Estimated Completion Date

April 2012

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

General Inclusion Criteria

Eligible for percutaneous coronary intervention (PCI).
Documented stable or unstable angina pectoris
Left ventricular ejection fraction (LVEF) ≥25%
Acceptable candidate for coronary artery bypass graft surgery (CABG).
Target lesion < 25 mm in length with RVD of 2.5 to 3.5 mm with visually estimated stenosis of >= 50 and < 100%

Exclusion Criteria:

General Exclusion Criteria

Known sensitivity to pimecrolimus, paclitaxel, the polymer (PLGA) or cobalt chromium.
Planned treatment with any other PCI device in the target vessel(s).
MI within 72 hours prior to the index procedure
The patient is in cardiogenic shock.
Cerebrovascular Accident (CVA) within the past 6 months.
Acute or chronic renal dysfunction
Contraindication to ASA or to clopidogrel.
Thrombocytopenia
Active gastrointestinal (GI) bleeding within the past 3 months.
Any prior true anaphylactiod reaction to contrast agents
Patient is currently taking colchicine, chronic systemic steroid therapy or systemic immunosuppressant therapy, or paclitaxel (systemic) within 12 months of the index procedure.
Female of childbearing potential.
Life expectancy of less than 24 months due to other medical conditions.
Co-morbid condition(s)
Currently participating in another investigational drug or device study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00322569

Responsible Party

Keith D. Dawkins, M.D., Principal Investigator, Southampton University Hospital

Study ID Numbers ^ICMJE

GENESIS Trial CP-01

Study Sponsor ^ICMJE

Cordis Corporation

Collaborators ^ICMJE

Conor Medsystems

Investigators ^ICMJE

Principal Investigator:	Keith D. Dawkins, M.D.	Southampton University Hospital
Principal Investigator:	Stefan Verheye, M.D.	AZ Middelheim Hospital

Information Provided By

Cordis Corporation

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP