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

NCT ID: NCT00322543

Last Updated: 2008-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-05-31

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.

Conditions

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Coronary Disease

Keywords

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Percutaneous coronary intervention (PCI) Drug eluting stent (DES)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug eluting stent

Corio™ Pimecrolimus-eluting stent

Group Type EXPERIMENTAL

Corio™ Pimecrolimus-eluting stent

Intervention Type DEVICE

Interventions

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Corio™ Pimecrolimus-eluting stent

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conor Medsystems

INDUSTRY

Sponsor Role lead

Responsible Party

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Institute Dante Pazzanese of Cardiology

Principal Investigators

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Alexandre Abizaid, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institute Dante Pazzanese of Cardiology

Locations

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Institute Dante Pazzanese of Cardiology

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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RAPID (Genesis) Registry CP-02

Identifier Type: -

Identifier Source: org_study_id