Status:
TERMINATED
Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID)
Lead Sponsor:
Conor Medsystems
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™ pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo lesions of the native coronary art...
Detailed Description
The registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the Corio™ drug-eluting stent.
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 to 3.5 mm with visually estimated stenosis of \>= 50 and \< 100 %.
Exclusion
- General Exclusion Criteria
- Known sensitivity to pimecrolimus, 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 chronic systemic steroid therapy or systemic immunosuppressant therapy or 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00322543
Start Date
May 1 2006
End Date
May 1 2008
Last Update
October 17 2008
Active Locations (1)
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1
Institute Dante Pazzanese of Cardiology
São Paulo, São Paulo, Brazil, 04012-180