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

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Corio™ Pimecrolimus-eluting stent

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Percutaneous coronary intervention (PCI), Drug eluting stent (DES)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: General Inclusion Criteria Eligible for percutaneous coronary intervention (PCI). Documented stable or unstable angina pectoris Left ventricular ejection fraction (LVEF) ≥25% Acceptable candidate for coronary artery bypass graft surgery (CABG). 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 Known sensitivity to pimecrolimus, the polymer (PLGA) or cobalt chromium. Planned treatment with any other PCI device in the target vessel(s). MI within 72 hours prior to the index procedure The patient is in cardiogenic shock. Cerebrovascular Accident (CVA) within the past 6 months. Acute or chronic renal dysfunction Contraindication to ASA or to clopidogrel. Thrombocytopenia Active gastrointestinal (GI) bleeding within the past 3 months. Any prior true anaphylactiod reaction to contrast agents Patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus. Female of childbearing potential. Life expectancy of less than 24 months due to other medical conditions. Co-morbid condition(s) Currently participating in another investigational drug or device study

Sites / Locations

Institute Dante Pazzanese of Cardiology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug eluting stent

Arm Description

Corio™ Pimecrolimus-eluting stent

Outcomes

Primary Outcome Measures

Angiographic endpoint of in-stent late lumen loss at 6 months

Secondary Outcome Measures

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;

Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months.

Full Information

NCT ID

NCT00322543

First Posted

May 4, 2006

Last Updated

October 16, 2008

Sponsor

Conor Medsystems

1. Study Identification

Unique Protocol Identification Number

NCT00322543

Brief Title

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

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Terminated

Study Start Date

May 2006 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Conor Medsystems

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug eluting stent

Arm Type

Experimental

Arm Description

Corio™ Pimecrolimus-eluting stent

Intervention Type

Device

Intervention Name(s)

Corio™ Pimecrolimus-eluting stent

Primary Outcome Measure Information:

Title

Angiographic endpoint of in-stent late lumen loss at 6 months

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Title

Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: General Inclusion Criteria Eligible for percutaneous coronary intervention (PCI). Documented stable or unstable angina pectoris Left ventricular ejection fraction (LVEF) ≥25% Acceptable candidate for coronary artery bypass graft surgery (CABG). 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 Known sensitivity to pimecrolimus, the polymer (PLGA) or cobalt chromium. Planned treatment with any other PCI device in the target vessel(s). MI within 72 hours prior to the index procedure The patient is in cardiogenic shock. Cerebrovascular Accident (CVA) within the past 6 months. Acute or chronic renal dysfunction Contraindication to ASA or to clopidogrel. Thrombocytopenia Active gastrointestinal (GI) bleeding within the past 3 months. Any prior true anaphylactiod reaction to contrast agents Patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus. Female of childbearing potential. Life expectancy of less than 24 months due to other medical conditions. Co-morbid condition(s) Currently participating in another investigational drug or device study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre Abizaid, M.D.

Organizational Affiliation

Institute Dante Pazzanese of Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute Dante Pazzanese of Cardiology

City

Sao Paulo

State/Province

SP

ZIP/Postal Code

04012-180

Country

Brazil

Coronary Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial