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

NCT00130546 | Completed Phase 3 DMC

• 1 other identifier: FreRace-Study 186/02
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; coronary intervention; drug eluting stent implantation; Cypher - Stent; Sirolimus; Taxus - Stent; Paclitaxel

Outcome Measures

Primary Outcomes (1)

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

  8 months

Secondary Outcomes (2)

• Target lesion and vessel revascularization (TLR, TVR)

  12 months

• Major adverse cardiac events (MACE) at 30 days, 8 and 12 months

  30 days, 8 and 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Cypher Stent

Device: Sirolimus eluting Cypher Select(TM)

2

ACTIVE COMPARATOR

Taxus Stent

Device: Paclitaxel-eluting TAXUS(TM)

Interventions

Paclitaxel-eluting TAXUS(TM) DEVICE

TAXUS(TM) Paclitaxel-eluting stent

2

Sirolimus eluting Cypher Select(TM) DEVICE

Sirolimus eluting Cypher Select(TM) stent

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Cordis Medizinische Apparate GmbH: collaborator

Study Sites (1)

Albert-Ludwig University Clinic

Freiburg im Breisgau, Baden-Wurttemberg, 79116, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Manfred Zehender, MD PhD

  University Clinic Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2005
• First Posted: August 15, 2005
• Study Start: November 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 15, 2009

Record last verified: 2009-05

Locations

DE (1)