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

University Hospital Freiburg

Status and phase

Completed

Phase 3

Conditions

Coronary Artery Disease

Treatments

Device: Paclitaxel-eluting TAXUS(TM)

Device: Sirolimus eluting Cypher Select(TM)

Study type

Interventional

Funder types

Other

Identifiers

NCT00130546

FreRace-Study 186/02

Details and patient eligibility

About

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).

Full 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.

Enrollment

112 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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