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

Conor Medsystems

Status and phase: Terminated; Phase 3

Conditions: Coronary Disease

Treatments: Device: Corio™ Pimecrolimus-eluting stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322543

RAPID (Genesis) Registry CP-02

Details and patient eligibility

About

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.

Full description

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

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Drug eluting stent

Experimental group

Description:

Corio™ Pimecrolimus-eluting stent

Treatment:

Device: Corio™ Pimecrolimus-eluting stent