Diabetes Drug Eluting Sirolimus Stent Experience in Restenosis Trial (DESSERT)

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

Inclusion Criteria:

1. The patient must be ≥ 18 years of age;
2. Female of childbearing potential must have a negative pregnancy test within 7days of enrollment and utilize reliable birth control for eight months after enrollment;
3. Patients with IDDM (Type I) treated for at least 3 months with documented HbA1c, or NIDDM (Type II) treated with oral antidiabetics for at least 3 months;
4. 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 patients with documented silent ischemia OR patient with previous (>24 hours) myocardial infarction with documented residual ischemia and/or viable myocardium;
5. Single or double stent treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multi-vessel disease can be included only if a maximum of two vessels require treatment with a maximum of three lesions in total, no more than two lesions per vessels. The two lesions in a single vessel must be >10 mm apart (visual estimate) and must be treated with the assigned stent.
6. Target vessel diameter at the lesion site is ≥ 2.50mm and ≤ 3.5mm in diameter (visual estimate);
7. Target lesion is ≥ 13mm and ≤ 25mm in length (visual estimate);
8. Target lesion stenosis is >50% and <100% (visual estimate);
9. At least TIMI II coronary flow;
10. Acceptable candidate for coronary artery bypass surgery (CABG);
11. Patient is willing to comply with the specified follow-up evaluation;
12. Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee;
13. Patient can be pretreated with aspirin and clopidogrel or, alternatively, aspirin alone plus a loading dose of 300 mg of clopidogrel before procedure completion in case of urgent PCI, and GPIIb IIIa inhibitors (Tirofiban or Abciximab)

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
2. Unprotected left main coronary disease with ≥50% stenosis;
3. Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
4. Have a target lesion in an arterial or venous by-pass graft;
5. Calcified lesion which cannot be successfully predilated;
6. Documented left ventricular ejection fraction ≤ 30%;
7. TIMI 0-I coronary flow ;
8. Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
9. Pretreatment with devices other than balloon angioplasty;
10. Target lesion has excessive tortuousity or angulation (>45°) which makes it unsuitable for stent delivery and deployment;
11. Target lesion involves bifurcation including a diseased side branch ≥2 mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting;
12. Prior stent within 5mm of target lesion;
13. Direct Stenting;
14. Recipient of heart transplant;
15. Patient with a life expectancy less than 12 months;
16. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix), heparin and GPIIb IIIa inhibitors (Tirofiban or Abciximab) stainless steel, contrast agent (that cannot be managed medically), or sirolimus;
17. Recent (6 months) cerebrovascular accidents or intracranial hemorrhage;
18. Any significant medical condition which in the investigator.s opinion may interfere with the patient.s optimal participation in the study;
19. Currently participating in an investigational drug or another device study;
20. Intervention of another lesion has occurred within 6 months before the index procedure;
21. In the investigator.s opinion, the lesion is not suitable for stenting.