Status:
COMPLETED
A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)
Lead Sponsor:
Cordis US Corp.
Collaborating Sponsors:
Conor Medsystems
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm and the dual pimecr...
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 s...
Eligibility Criteria
Inclusion
- 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 mm to ≤3.5 mm with visually estimated stenosis of ≥50% and \< 100% .
- Target vessel had not undergone prior revascularization within the preceding 6 months.
- Target lesion must have been a minimum of 10 mm distance from any previously treated segment of the target vessel
- Patient understood the study requirements and the treatment procedures and provided written Informed Consent, approved by the local Ethics Committee.
- Willing to comply with all specified follow-up evaluations.
Exclusion
- 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 or had been treated with paclitaxel (systemic) within 12 months of the index procedure.
- Patient was currently, or was on long term intermittent therapy with topical pimecrolimus
- 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
- General Angiographic
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00322569
Start Date
July 1 2006
End Date
May 1 2012
Last Update
March 6 2013
Active Locations (1)
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1
Southampton University Hospital
Southampton, United Kingdom, SO16 YD