The Study of the Crushing Technique Application Using SES in Coronary Bifurcations. (CACTUS)

This is an interventional treatment trial for Coronary Artery Disease Read More

Inclusion Criteria:

1. Is a male or non-pregnant female patient >= 18 years of age [NOTE: Females of child-bearing potential must have a negative pregnancy test];
2. 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;
3. Has at least TIMI I coronary flow in both the main and side branches;
4. 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;
5. Has a true bifurcation lesion defined as stenosis > 50% in both the main branch and the ostium of the side branch;
6. Has a maximum treatable main or side branch lesion length <=28 mm;
7. Has a main branch vessel that is >= 2.5 mm and <= 3.5 mm in diameter by on-line QCA proximal to the bifurcation;
8. Has a side branch vessel that is >= 2.25 mm and <= 3.5 mm in diameter by on-line QCA;
9. Is an acceptable candidate for coronary artery bypass surgery (CABG);
10. Is willing to comply with the specified follow-up evaluation;
11. The patient or legally authorized representative must provide written informed consent prior to the procedure.

Exclusion Criteria:

1. 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;
2. Has unstable angina classified as Braunwald A I-III, B&C III;
3. Has a bifurcation lesion in a non protected left main;
4. Has an ejection fraction <= 35%;
5. Has known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or sirolimus;
6. Has a known serious allergy to contrast media or stainless steel that cannot be managed medically;
7. Has impaired renal function (creatinine > 3.0 mg/dl);
8. There is presence of thrombus in the bifurcation lesion;
9. Has a target lesion with excessive tortuousity unsuitable for stent delivery and deployment;
10. Has a totally occluded vessel;
11. Is the recipient of a heart transplant;
12. Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
13. Is currently participating in an investigational drug or another device study.