Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments mistent des, endeavor des
Phase phase 2
Sponsor Micell Technologies
Start date February 2011
End date June 2012
Trial size 184 participants
Trial identifier NCT01294748, MIS-CEM-2010-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
The MiStent SES is a sirolimus-eluting absorbable polymer stent for coronary artery revascularization.
mistent des
The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
(Active Comparator)
The Endeavor DES is an everolimus-eluting durable polymer stent for coronary artery revascularization.
endeavor des
The Endeavor is a device/drug combination comprised of two components; a stent and a drug product (everolimus within a durable polymer coating).

Primary Outcomes

Measure
In-Stent Late Lumen Loss
time frame: 9 months
Major Adverse Cardiac Events (MACE)
time frame: 9 months

Secondary Outcomes

Measure
Device Success
time frame: 8 hours
Lesion Success
time frame: 8 hours
Procedural Success
time frame: 8 hours
Total Mortality
time frame: 9-months
Total Myocardial Infarct (MI)
time frame: 9-months
Clinically-driven Target Lesion Revascularization (TVR)
time frame: 9-months
Target Vessel Failure (TVF)
time frame: 9-months
Target Lesion Failure (TLF)
time frame: 9-months
Stent Thrombosis (Definite/Probable)
time frame: 9-months

Eligibility Criteria

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

Inclusion Criteria: 1. Age ≥18 and ≤85 years; 2. Stable/unstable angina pectoris (Class I-IV), documented ischemia/silent ischemia; 3. Planned single, de novo, types A, B1 or B2 coronary lesions; 4. Target lesion located in a native coronary artery; 5. Target lesion in vessel ranging from 2.5 to 3.5 mm amenable to treatment (coverage) with a 30 mm long stent; 6. Target lesion with >50% diameter stenosis; 7. Recent Q-wave (>72 hours) or non-Q-wave myocardial infarction; 8. Patients eligible for PCI; 9. Candidate for CABG ; 10. A patient may have one additional critical non-target lesion. 11. Patient capable of providing informed consent and is willing to comply with all study requirements. Exclusion Criteria: 1. 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; 2. Recent Q-wave MI < 72 hours prior to the index procedure. 3. 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); 4. LVEF <30% (within the previous 6-months); 5. Patients in cardiogenic shock; 6. CVA or TIA within the past 6 months; 7. Active GI bleeding within past 3 months; 8. Any prior anaphylactic reaction to contrast agents; 9. Chemotherapy within 30-days before or after the index procedure; 10. Receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease; 11. Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L); 12. Platelet count <100,000 cells/mm³ or >700,000 cells/mm³; 13. White blood cell count <3,000 cells/mm3; 14. Hepatic disease; 15. Heart transplant recipient; 16. Known contraindication to DAPT; 17. Known hypersensitivity to sirolimus, cobalt-chromium, or to medications such as aspirin, heparin and Angiomax (bivalirudin), and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient); 18. Life expectancy less than 12 months; 19. Any major medical condition that may interfere with participation in this study; 20. Patient is currently participating in an investigational drug or another device study and has not completed the follow-up to the primary endpoint, or the patient is planning on participating prior to completing 12-months follow-up; 21. Target vessel has been treated within 10 mm proximal or distal to target lesion with any type of PCI or within a year prior to index procedure; 22. 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; 23. Patient previously treated at any time with brachytherapy; 24. Planned coronary angioplasty or CABG in the first 9 months after the index procedure or any other planned intervention within 30-days post index procedure; 25. Prior PCI of a non-target vessel must be at least 14 days prior to study enrollment; 26. The intent to direct stent the target lesion; 27. Angiographic Exclusion Criteria: - In-stent restenotic target lesion; - 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; - Long target lesion not amenable to treatment with up to a 30 mm long stent; - Left main critical disease (≥50% DS); - Target lesion is located in a surgical bypass graft; - Total target vessel occlusion (TIMI flow grade 0-1); - Target lesion ostial location; - Target lesion at bifurcation involving side branch >2.5 mm or lateral branch that also requires stenting; - Calcified target lesion that anticipates unsuccessful/impracticable predilation; - Target vessel with excessive tortuosity or proximal angulation; - 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: 1. Located within the target vessel; 2. Located within a bypass graft ; 3. Left main location; 4. Chronic total occlusion 5. Involves a complex bifurcation.

Additional Information

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