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

October 16, 2008 updated by: Conor Medsystems

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04012-180
        • Institute Dante Pazzanese of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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;
Time Frame: 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.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Conor Medsystems

Investigators

  • Principal Investigator: Alexandre Abizaid, M.D., Institute Dante Pazzanese of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 4, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

October 17, 2008

Last Update Submitted That Met QC Criteria

October 16, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAPID (Genesis) Registry CP-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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