Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment mistent ses
Phase phase 2
Sponsor Micell Technologies
Start date November 2010
End date September 2012
Trial size 30 participants
Trial identifier NCT01247428, MIS-FIH-2010-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
mistent ses
The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).

Primary Outcomes

Measure
Angiographic In-Stent Late Lumen Loss
time frame: 8 months

Secondary Outcomes

Measure
Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)
time frame: 240 days
Device Success
time frame: 8 hours
Lesion Success
time frame: 8 hours
Procedural Success
time frame: 8 hours
Total Mortality
time frame: 240 days
Total Myocardial Infarction (MI)
time frame: 240 days
Clinically-driven Target Lesion Revascularization (TLR) Rates
time frame: 240 days
Clinically-driven Target Vessel Revascularization (TVR) Rates
time frame: 240 days
Target Vessel Failure (TVF)
time frame: 240 days
Target Lesion Failure (TLF)
time frame: 240 days
Stent Thrombosis
time frame: 240 days
Angiographic Evaluation: In-stent Binary Restenosis
time frame: 4 months, 6 months, 8 months
Angiographic Evaluation: In-stent Binary Restenosis
time frame: 18 months
Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction
time frame: 8 months
IVUS Evaluation: % Neointimal Volume Obstruction
time frame: 18 months
Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered
time frame: 8 months
OCT Evaluation: % Stent Strut Uncovered
time frame: 18 M

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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 <100,000 cells/mm³ or >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 <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.

Additional Information

Official title 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
Principal investigator William Wijns, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Micell Technologies.