Intra-Individual Comparison of Sirolimus and Paclitaxel Coated Stent (FRE–RACE Study) - Full Text View

Sponsors and Collaborators:	University Hospital Freiburg Cordis Medizinische Apparate GmbH
Information provided by:	University Hospital Freiburg
ClinicalTrials.gov Identifier:	NCT00130546

Purpose

The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses (prospective, randomized, intra-individual comparison).

Condition	Intervention	Phase
Coronary Artery Disease	Device: Percutaneous transluminal coronary angioplasty and drug eluting stent implantation	Phase III

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Paclitaxel Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized Intra-Individual Study With the Sirolimus Coated Cypher Select(TM) and the Paclitaxel(TM) Coated Express Balloon Expandable Stents for the Treatment of Patients With Two de Novo Native Coronary Artery Lesions.

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:

The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography

Secondary Outcome Measures:

In-stent mean percent diameter stenosis (%DS)
In-lesion minimal lumen diameter (MLD) within the stented segment
In-stent MLD within the stented segment
Target lesion and vessel revascularization (TLR, TVR)
Major adverse cardiac events (MACE) at 30 days, 8 and 12 months

Estimated Enrollment:	110
Study Start Date:	November 2004
Estimated Study Completion Date:	July 2007

Detailed Description:

This is a prospective, 2 arm, randomized, multicenter Phase III study (6 centers).

A total of 110 patients with at least two de novo native coronary artery lesions (lesion A, lesion B) ≤30 mm in length and ≥2.25 mm to <3.0 mm in diameter by visual estimate will be enrolled. Patients will be randomized for implantation of the sirolimus eluting Cypher Select(TM) Balloon-Expandable Stent or to the TAXUS(TM) Paclitaxel-eluting stent for lesion A and B.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient must be >=18 and <=85 years of age
Female of childbearing potential must have a negative pregnancy test at the time of enrolment and utilize reliable birth control for the duration of their participation in the trial
Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) and documented ischemia OR patients with documented silent ischemia
Two or more de novo lesions <30mm in length (visual estimate)
Target vessel at lesion site is ≥2.25 mm and ≤3.0 mm in diameter (visual estimate)
Target lesion is located in a native coronary artery which can be covered by one stent (single lesion)
Acceptable candidate for coronary artery bypass surgery (CABG)
Target lesion stenosis is >50% and <100% (thrombolysis in myocardial infarction [TIMI] 1) (visual estimate)
Target lesions do not differ in length for more than 6mm
Patient is willing to comply with the specified follow-up evaluation
Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee

Exclusion Criteria:

Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal
Unprotected left main coronary disease with >= 50% stenosis
Impaired runoff in the treatment vessel with diffuse distal disease
Ostial target lesion
Angiographic evidence of thrombus within target lesion
Calcified lesions which cannot be successfully predilated
Ejection fraction <= 30%
Totally occluded vessel (TIMI 0 level)
Impaired renal function (creatinine > 3.0 mg/dl)
Pretreatment with devices other than balloon angioplasty
Target lesion has excessive tortuosity unsuitable for stent delivery and deployment
Target lesion involves bifurcation including a side branch >= 2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented
Prior stent within 5 mm of target lesion this includes in-stent restenosis.
Significant (>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff
Intervention of another lesion has occurred within one month before or is planned or highly probable to be performed within the next 30 days after this index procedure
Recipient of heart transplant
Patient with a life expectancy less than 12 months
Known allergies to aspirin, clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®), heparin stainless steel, contrast agent, Paclitaxel or Sirolimus.
Any significant medical condition which in the investigator‘s opinion may interfere with the patient‘s optimal participation in the study
Target lesion located in an arterial or venous by-pass graft
Currently participating in an investigational drug or another device study
Unstable angina pectoris Braunwald Classification A I-II-III or is having a peri-infarction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130546

Contacts

Contact: Manfred Zehender, MD PhD	++49 761 270 ext 3332	manfred.zehender@uniklinik-freiburg.de
Contact: Marc Kollum, MD	++49 761 270 ext 3618	marc.kollum@uniklinik-freiburg.de

Locations

Germany, Baden-Württemberg
Albert-Ludwig University Clinic	Recruiting
Freiburg, Baden-Württemberg, Germany, 79116
Contact: Manfred Zehender, MD PhD ++49 761 270 ext 3332 manfred.zehender@uniklinik-freiburg.de
Contact: Marc Kollum, MD ++49 761 270 ext 3618 marc.kollum@uniklinik-freiburg.de
Sub-Investigator: Marc Kollum, MD

Sponsors and Collaborators

University Hospital Freiburg

Cordis Medizinische Apparate GmbH

Investigators

Principal Investigator:

Manfred Zehender, MD PhD

University Clinic Freiburg

More Information

Study ID Numbers:	FreRace-Study 186/02
Study First Received:	August 11, 2005
Last Updated:	April 25, 2007
ClinicalTrials.gov Identifier:	NCT00130546
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Freiburg:

coronary artery disease
coronary intervention
drug eluting stent implantation
Cypher - Stent

Sirolimus
Taxus - Stent
Paclitaxel

Study placed in the following topic categories:

Arterial Occlusive Diseases
Sirolimus
Heart Diseases
Clotrimazole
Myocardial Ischemia
Miconazole
Vascular Diseases

Tioconazole
Ischemia
Arteriosclerosis
Coronary Disease
Paclitaxel
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Tubulin Modulators
Cardiovascular Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009