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

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130546
• Other study ID #: FreRace-Study 186/02
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2005
• Last updated: May 14, 2009
• Start date: November 2004
• Est. completion date: July 2008

Study information

• Verified date: May 2009
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Paclitaxel-eluting TAXUS(TM)
TAXUS(TM) Paclitaxel-eluting stent
• Sirolimus eluting Cypher Select(TM)
Sirolimus eluting Cypher Select(TM) stent

Locations

Country	Name	City	State
Germany	Albert-Ludwig University Clinic	Freiburg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	Cordis Medizinische Apparate GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography		8 months	No
Secondary	Target lesion and vessel revascularization (TLR, TVR)		12 months	Yes
Secondary	Major adverse cardiac events (MACE) at 30 days, 8 and 12 months		30 days, 8 and 12 months	Yes