NCT00322543TerminatedPhase 3
Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID) A Multi-Center Study of the Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System (Corio™) in Patients With De Novo Lesions of the Native Coronary Arteries
Conor Medsystems2 sites in 1 country3 target enrollmentStarted: May 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Angiographic endpoint of in-stent late lumen loss at 6 months
Study Overview
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 arteries.
Detailed Description
The registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the Corio™ drug-eluting stent.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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, 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
Outcomes
Primary Outcomes
Angiographic endpoint of in-stent late lumen loss at 6 months
Time Frame: 6 months
Secondary Outcomes
- Major Adverse Cardiac Events (MACE) defined as an adjudicated composite of clinically driven target vessel revascularization, new myocardial infarction (MI) or cardiac death at 30 days, 6 months, 12 months and 2 years;(30 days, 6 months, 12 months and 2 years)
- Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months.(6 months)
Investigators
Study Sites (2)
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