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

Sponsored by:	Conor Medsystems
Information provided by:	Conor Medsystems
ClinicalTrials.gov Identifier:	NCT00322543

Purpose

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.

Condition	Intervention	Phase
Coronary Disease	Device: Corio™ Pimecrolimus-eluting stent	Phase III

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Pimecrolimus Chromium Cobalt

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Conor Medsystems:

Primary Outcome Measures:

Angiographic endpoint of in-stent late lumen loss at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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; [ Time Frame: 30 days, 6 months, 12 months and 2 years ] [ Designated as safety issue: Yes ]
Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	May 2006
Study Completion Date:	May 2008
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Drug eluting stent: Experimental Corio™ Pimecrolimus-eluting stent	Device: Corio™ Pimecrolimus-eluting stent

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322543

Locations

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

Sponsors and Collaborators

Conor Medsystems

Investigators

Principal Investigator:

Alexandre Abizaid, M.D.

Institute Dante Pazzanese of Cardiology

More Information

Responsible Party:	Institute Dante Pazzanese of Cardiology ( Alexandre Abizaid, MD )
Study ID Numbers:	RAPID (Genesis) Registry CP-02
Study First Received:	May 4, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00322543
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Conor Medsystems:

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Chromium
Cobalt
Myocardial Ischemia

Vascular Diseases
Pimecrolimus
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses

Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 14, 2009