A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems - Full Text View

Sponsored by:	Conor Medsystems
Information provided by:	Conor Medsystems
ClinicalTrials.gov Identifier:	NCT00322569

Purpose

Randomized, three-arm, multi-center, clinical trial evaluating the Corio™ Pimecrolimus and SymBio™ Pimecrolimus/Paclitaxel-eluting stents compared to the CoStar™ in patients with de novo lesions of the native coronary arteries.

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

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Paclitaxel Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multi-Center Study of the Pimecrolimus-Eluting (Corio™) and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System (SymBio™) in Patients With De Novo Lesions of the Native Coronary Arteries

Further study details as provided by Conor Medsystems:

Primary Outcome Measures:

Primary angiographic late loss in the stent at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MACE defined as cardiac death, new MI, or TVR at 30 days and 6 months, 1, 2, 3, 4 and 5 years; Device, Lesion and Procedure Success; coronary angiography at 6 months; IVUS measurements in IVUS coh [ Time Frame: 30 days and 6 months, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]

Enrollment:	246
Study Start Date:	July 2006
Estimated Study Completion Date:	April 2012
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pimecrolimus-ElutinG Cobalt Chromium Coronary Stent System	Device: Corio™ Pimecrolimus-eluting stent Drug-eluting stent
2: Experimental SymBio™ Pimecrolimus/Paclitaxel-eluting stent	Device: SymBio™ Pimecrolimus/Paclitaxel-eluting stent Drug-eluting stent

Detailed Description:

This study is designed to evaluate 6 month in-stent late lumen loss of the 1) Corio™ pimecrolimus-eluting coronary stent system and the 2) SymBio™ dual pimecrolimus/paclitaxel-eluting coronary stent system compared to the CoStar™ Paclitaxel-Eluting Coronary Stent System control arm.

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, paclitaxel, 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 colchicine, chronic systemic steroid therapy or systemic immunosuppressant therapy, or paclitaxel (systemic) within 12 months of the index procedure.
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: NCT00322569

Locations

United Kingdom
Southampton University Hospital
Southampton, United Kingdom, SO16 YD

Sponsors and Collaborators

Conor Medsystems

Investigators

Principal Investigator:	Keith D. Dawkins, M.D.	Southampton University Hospital
Principal Investigator:	Stefan Verheye, M.D.	AZ Middelheim Hospital

More Information

Responsible Party:	Southampton University Hospital ( Keith D. Dawkins, M.D., Principal Investigator )
Study ID Numbers:	GENESIS Trial CP-01
Study First Received:	May 4, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00322569
Health Authority:	United Kingdom: National Health Service

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
Paclitaxel
Myocardial Ischemia
Vascular Diseases

Pimecrolimus
Tacrolimus
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Tubulin Modulators
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009