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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130546
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : May 15, 2009
Cordis Medizinische Apparate GmbH
Information provided by:
University Hospital Freiburg

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: Paclitaxel-eluting TAXUS(TM) Device: Sirolimus eluting Cypher Select(TM) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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.
Study Start Date : November 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Target lesion and vessel revascularization (TLR, TVR) [ Time Frame: 12 months ]
  2. Major adverse cardiac events (MACE) at 30 days, 8 and 12 months [ Time Frame: 30 days, 8 and 12 months ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00130546

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

Responsible Party: Prof. Dr. Zehender, University Hospital Freiburg Identifier: NCT00130546     History of Changes
Other Study ID Numbers: FreRace-Study 186/02
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009

Keywords provided by University Hospital Freiburg:
coronary artery disease
coronary intervention
drug eluting stent implantation
Cypher - Stent
Taxus - Stent

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