first-in-human trial of the mistent drug-eluting stent (des) in coronary artery disease

Conditions: Coronary Artery Disease

Summary: the dessolve i clinical trial is to assess the safety and performance of the sirolimus-eluting mistent ses.

the dessolve i clinical trial is to assess the safety and performance of the sirolimus-eluting mistent for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions \< 20 mm in length in the native coronary arteries with reference vessel diameters between 2.5 mm and 3.5 mm.

Eligibility criteria:
inclusion criteria: 1. male/female patients 18-85 years; 2. stable or unstable angina pectoris, ischemia, or silent ischemia; 3. planned single, de novo, types a, b1 and b2 coronary lesions; 4. target lesion located in a native coronary artery; 5. target lesion vessel diameter 2.5 to 3.5 mm amenable to treatment with a maximum 23 mm long stent; 6. target lesion \>50% diameter stenosis; 7. patients eligible for percutaneous coronary intervention (pci); 8. acceptable candidate for myocardial revascularization surgery; 9. a patient may have one additional critical non-target lesion. 10. the patient will provide written informed consent. exclusion criteria: 1. female of childbearing potential not on some form of birth control with a confirmed negative pregnancy test at baseline; 2. recent q-wave myocardial infarction occurred \<72 hours prior to the index procedure. recent myocardial infarction with elevated levels of cardiac markers; 3. left ventricular ejection fraction \<30%; 4. patients in cardiogenic shock; 5. cerebrovascular accident or transient ischemic attack within 6 months; 6. active gi bleed within three months; 7. any prior true anaphylactic reaction to contrast agents; 8. patient receiving/scheduled to receive chemotherapy within 30-days before or after the index procedure; 9. patient is receiving immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease; 10. renal dysfunction (creatinine \> 2.0 mg/dl or 177 µmol/l); 11. platelet count \ 700,000 cells/mm³; 12. white blood cell count \<3,000 cells/mm3; 13. hepatic disease; 14. heart transplant recipient; 15. known contraindication to dual antiplatelet therapy; 16. known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin, and all three of the following: clopidogrel bisulfate (plavix), ticlopidine (ticlid), and prasugrel (effient); 17. life expectancy \<12 months; 18. any major medical condition that may interfere with the optimal participation of the patient in this study; 19. patient is currently participating/planning to participate in an investigational drug or another device study prior to completing 12-months follow-up; 20. target vessel(s) has been treated within 10 mm proximal or distal to target lesion with any type of pci within a year prior to index procedure; 21. planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter prior to stent placement; 22. previous coronary intravascular brachytherapy; 23. planned coronary angioplasty or coronary artery bypass grafting (cabg)in the first 9 months after the index procedure; 24. prior pci of a non-target vessel must be at least 30 days prior to study enrollment; 25. the intent to direct stent the target lesion; 26. angiographic exclusion criteria: assessed prior to stent placement; * in-stent restenotic target lesion; * more than one lesion requiring treatment in the target vessel; * target vessel diameter \ 3.5 mm; * target lesion not amenable to treatment with a 23 mm long stent; * unprotected coronary artery branch lesion (≥50% ds); * target lesion located in a surgical bypass graft; * total vessel occlusion; * target lesion with ostial location; * target lesion located in a lateral branch bifurcation \>2.5mm or requiring lateral branch stenting; * calcified target lesion that anticipates unsuccessful/impracticable predilation; * target vessel excessive tortuosity or proximal angulation (\>90 degrees); * thrombus present in target vessel; * more than one non-target critical lesion; non-target lesion to be treated during the index procedure meets any of the following criteria: * within the target vessel; * within a bypass graft; * left main location; * chronic total occlusion; * involves a complex bifurcation.

Keywords: coronary artery disease drug-eluting stent sirolimus