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

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00322543
• Other study ID #: RAPID (Genesis) Registry CP-02
• Status: Terminated
• Phase: Phase 3
• First received: May 4, 2006
• Last updated: October 16, 2008
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: September 2008
• Source: Conor Medsystems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2008
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Corio™ Pimecrolimus-eluting stent

Locations

Country	Name	City	State
Brazil	Institute Dante Pazzanese of Cardiology	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Conor Medsystems

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic endpoint of in-stent late lumen loss at 6 months		6 months	No
Secondary	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	Yes
Secondary	Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months.		6 months	No