Clinical Investigation of a DES (MiStent™ System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in Native Coronary Arteries.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Micell Technologies
- Enrollment
- 184
- Locations
- 28
- Primary Endpoint
- In-Stent Late Lumen Loss
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The DESSOLVE II 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 in the native coronary arteries.
Detailed Description
The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent as compared to the Endeavor DES for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions in the native coronary arteries.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 and ≤85 years;
- •Stable/unstable angina pectoris (Class I-IV), documented ischemia/silent ischemia;
- •Planned single, de novo, types A, B1 or B2 coronary lesions;
- •Target lesion located in a native coronary artery;
- •Target lesion in vessel ranging from 2.5 to 3.5 mm amenable to treatment (coverage) with a 30 mm long stent;
- •Target lesion with \>50% diameter stenosis;
- •Recent Q-wave (\>72 hours) or non-Q-wave myocardial infarction;
- •Patients eligible for PCI;
- •Candidate for CABG ;
- •A patient may have one additional critical non-target lesion.
Exclusion Criteria
- •Female patients of childbearing potential who do not have a confirmed negative pregnancy test at baseline and are not on some form of birth control;
- •Recent Q-wave MI \< 72 hours prior to the index procedure.
- •Recent Q- or non-Q-wave MI with still elevated levels of cardiac markers (e.g. CK; and CK-MB if the CK is elevated);
- •LVEF \<30% (within the previous 6-months);
- •Patients in cardiogenic shock;
- •CVA or TIA within the past 6 months;
- •Active GI bleeding within past 3 months;
- •Any prior anaphylactic reaction to contrast agents;
- •Chemotherapy within 30-days before or after the index procedure;
- •Receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease;
Outcomes
Primary Outcomes
In-Stent Late Lumen Loss
Time Frame: 9 months
Measured by the angiographic core laboratory as the difference between the post-procedure MLD in the treated segment (stented region) minus the MLD in the same region at follow-up
Major Adverse Cardiac Events (MACE)
Time Frame: 9 months
Defined as death, MI (Qwave and non-Q-wave) and TVR at 9 months post-procedure. Assessed on all patients with adequate follow-up at 270 days.
Secondary Outcomes
- Device Success(8 hours)
- Total Mortality(9-months)
- Target Vessel Failure (TVF)(9-months)
- Lesion Success(8 hours)
- Stent Thrombosis (Definite/Probable)(9-months)
- Procedural Success(8 hours)
- Clinically-driven Target Lesion Revascularization (TVR)(9-months)
- Total Myocardial Infarct (MI)(9-months)
- Target Lesion Failure (TLF)(9-months)