Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID)

Study Overview
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Brief Summary
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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
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The registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the Corio™ drug-eluting stent.

Official Title
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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

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: Corio™ Pimecrolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug eluting stent<br>Corio™ Pimecrolimus-eluting stent | Device: Corio™ Pimecrolimus-eluting stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic endpoint of in-stent late lumen loss at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention (PCI), Drug eluting stent (DES)