First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease

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.

Inclusion criteria

• Male/female patients 18-85 years;
• Stable or unstable angina pectoris, ischemia, or silent ischemia;
• Planned single, de novo, types A, B1 and B2 coronary lesions;
• Target lesion located in a native coronary artery;
• Target lesion vessel diameter 2.5 to 3.5 mm amenable to treatment with a maximum 23 mm long stent;
• Target lesion >50% diameter stenosis;
• Patients eligible for percutaneous coronary intervention (PCI);
• Acceptable candidate for myocardial revascularization surgery;
• A patient may have one additional critical non-target lesion.
• The patient will provide written informed consent.

Exclusion criteria

• Female of childbearing potential not on some form of birth control with a confirmed negative pregnancy test at baseline;
• Recent Q-wave myocardial infarction occurred <72 hours prior to the index procedure. Recent myocardial infarction with elevated levels of cardiac markers;
• Left ventricular ejection fraction <30%;
• Patients in cardiogenic shock;
• Cerebrovascular accident or transient ischemic attack within 6 months;
• Active GI bleed within three months;
• Any prior true anaphylactic reaction to contrast agents;
• Patient receiving/scheduled to receive chemotherapy within 30-days before or after the index procedure;
• Patient is receiving immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease;
• Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);
• Platelet count <100,000 cells/mm³ or >700,000 cells/mm³;
• White blood cell count <3,000 cells/mm3;
• Hepatic disease;
• Heart transplant recipient;
• Known contraindication to dual antiplatelet therapy;
• 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);
• Life expectancy <12 months;
• Any major medical condition that may interfere with the optimal participation of the patient in this study;
• Patient is currently participating/planning to participate in an investigational drug or another device study prior to completing 12-months follow-up;
• 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;
• 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;
• Previous coronary intravascular brachytherapy;
• Planned coronary angioplasty or coronary artery bypass grafting (CABG)in the first 9 months after the index procedure;
• Prior PCI of a non-target vessel must be at least 30 days prior to study enrollment;
• The intent to direct stent the target lesion;
• 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 <2.5 mm or >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.