Clinical trial NCT00322543: Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Coronary Disease
Keywords: Percutaneous coronary intervention (PCI)
Drug eluting stent (DES)
Lead sponsor: Conor Medsystems
Sponsor class: INDUSTRY
First posted: 2006-05-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria

1. Eligible for percutaneous coronary intervention (PCI).
2. Documented stable or unstable angina pectoris
3. Left ventricular ejection fraction (LVEF) ≥25%
4. Acceptable candidate for coronary artery bypass graft surgery (CABG).
5. 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

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

Primary outcomes:
measure: Angiographic endpoint of in-stent late lumen loss at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: 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;
timeFrame: 30 days, 6 months, 12 months and 2 years
measure: Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months.
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute Dante Pazzanese of Cardiology
state: SP
Study officials:
affiliation: Institute Dante Pazzanese of Cardiology
name: Alexandre Abizaid, M.D.
role: PRINCIPAL_INVESTIGATOR
References: