A First-In-Human Trial of a New Novel DES (MiStent System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries

Micell Technologies5 sites in 3 countries30 target enrollmentNovember 2010

ConditionsCoronary Artery Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Micell Technologies
Enrollment: 30
Locations: 5
Primary Endpoint: Angiographic In-Stent Late Lumen Loss
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

March 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Micell Technologies

Responsible Party

Sponsor

Eligibility Criteria

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);

Outcomes

Primary Outcomes

Angiographic In-Stent Late Lumen Loss

Time Frame: 8 months

In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up.

Secondary Outcomes

Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)(240 days)
Procedural Success(8 hours)
Clinically-driven Target Lesion Revascularization (TLR) Rates(240 days)
Target Vessel Failure (TVF)(240 days)
Device Success(8 hours)
Total Myocardial Infarction (MI)(240 days)
Clinically-driven Target Vessel Revascularization (TVR) Rates(240 days)
Stent Thrombosis(240 days)
Angiographic Evaluation: In-stent Binary Restenosis(18 months)
Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered(8 months)
Lesion Success(8 hours)
Total Mortality(240 days)
Target Lesion Failure (TLF)(240 days)
Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction(8 months)
IVUS Evaluation: % Neointimal Volume Obstruction(18 months)
OCT Evaluation: % Stent Strut Uncovered(18 M)