Status:
COMPLETED
The Study of the Crushing Technique Application Using SES in Coronary Bifurcations.
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to compare the safety and effectiveness of two different approaches to treat bifurcational lesions with CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Sten...
Detailed Description
This is a prospective, randomized study that will be conducted at up to 5 centers in Italy. All patients who meet the eligibility criteria will be treated with the Cypher SelectTM Stent and Stent Deli...
Eligibility Criteria
Inclusion
- Is a male or non-pregnant female patient \>= 18 years of age \[NOTE: Females of child-bearing potential must have a negative pregnancy test\];
- Has a 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) OR has documented silent ischemia;
- Has at least TIMI I coronary flow in both the main and side branches;
- Involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
- Has a true bifurcation lesion defined as stenosis \> 50% in both the main branch and the ostium of the side branch;
- Has a maximum treatable main or side branch lesion length \<=28 mm;
- Has a main branch vessel that is \>= 2.5 mm and \<= 3.5 mm in diameter by on-line QCA proximal to the bifurcation;
- Has a side branch vessel that is \>= 2.25 mm and \<= 3.5 mm in diameter by on-line QCA;
- Is an acceptable candidate for coronary artery bypass surgery (CABG);
- Is willing to comply with the specified follow-up evaluation;
- The patient or legally authorized representative must provide written informed consent prior to the procedure.
Exclusion
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented elevation of CK levels \> 2 times normal or CK-MB levels \> 3 times normal within the preceding 24 hours and/or the CK and CK-MB enzymes remain above normal at the time of treatment;
- Has unstable angina classified as Braunwald A I-III, B\&C III;
- Has a bifurcation lesion in a non protected left main;
- Has an ejection fraction \<= 35%;
- Has known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or sirolimus;
- Has a known serious allergy to contrast media or stainless steel that cannot be managed medically;
- Has impaired renal function (creatinine \> 3.0 mg/dl);
- There is presence of thrombus in the bifurcation lesion;
- Has a target lesion with excessive tortuousity unsuitable for stent delivery and deployment;
- Has a totally occluded vessel;
- Is the recipient of a heart transplant;
- Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
- Is currently participating in an investigational drug or another device study.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00749424
Start Date
January 1 2004
End Date
April 1 2009
Last Update
February 4 2010
Active Locations (1)
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1
Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy, 20132