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Intra-Individual Comparison of Sirolimus and Paclitaxel Coated Stent (FRE-RACE Study)

This study has been completed.
Sponsor:
Collaborator:
Cordis Medizinische Apparate GmbH
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00130546
First received: August 11, 2005
Last updated: May 14, 2009
Last verified: May 2009
History of Changes
  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: Paclitaxel-eluting TAXUS(TM)
Device: Sirolimus eluting Cypher Select(TM)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

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 [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Target lesion and vessel revascularization (TLR, TVR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Major adverse cardiac events (MACE) at 30 days, 8 and 12 months [ Time Frame: 30 days, 8 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 112
Study Start Date: November 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cypher Stent
 Device: Sirolimus eluting Cypher Select(TM)
Sirolimus eluting Cypher Select(TM) stent
Active Comparator: 2
Taxus Stent
 Device: Paclitaxel-eluting TAXUS(TM)
TAXUS(TM) Paclitaxel-eluting stent

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 < 30 mm 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 6 mm
  • 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 >= 2.5 mm 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

Locations
Germany
Albert-Ludwig University Clinic
Freiburg, Baden-Württemberg, Germany, 79116
Sponsors and Collaborators
University Hospital Freiburg
Cordis Medizinische Apparate GmbH
Investigators
Principal Investigator: Manfred Zehender, MD PhD University Clinic Freiburg
  More Information

No publications provided

Responsible Party: Prof. Dr. Zehender, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT00130546     History of Changes
Other Study ID Numbers: FreRace-Study 186/02
Study First Received: August 11, 2005
Last Updated: May 14, 2009
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 19, 2013