Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease (DESSOLVE-II)
|ClinicalTrials.gov Identifier: NCT01294748|
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : March 26, 2014
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: MiStent DES Device: Endeavor DES||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||February 2011|
|Primary Completion Date :||June 2012|
|Study Completion Date :||August 2016|
Experimental: MiStent DES
The MiStent SES is a sirolimus-eluting absorbable polymer stent for coronary artery revascularization.
Device: 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: Endeavor DES
The Endeavor DES is an everolimus-eluting durable polymer stent for coronary artery revascularization.
Device: 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).
- 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.
- Device Success [ Time Frame: 8 hours ]Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only.
- Lesion Success [ Time Frame: 8 hours ]Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.
- Procedural Success [ Time Frame: 8 hours ]Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, MI or repeat revascularization of the target lesion pre-hospital discharge.
- Total Mortality [ Time Frame: 9-months ]
- Total Myocardial Infarct (MI) [ Time Frame: 9-months ]
- Q-wave MI (QWMI): requires one of the following criteria: development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x ULN elevation of CK levels; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.
- Non-Q-wave MI (NQWMI):the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels (≥3 times ULN) in the absence of new pathologic Q waves.
- Peri-Procedural MI post PCI:Q or non-Q-wave MI, as defined above, prior to hospital discharge, or CK-MB elevation >3xULN within 48 hours post -PCI, with a normal CK-MB at baseline.
- Clinically-driven Target Lesion Revascularization (TVR) [ Time Frame: 9-months ]TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel (main branch or side branch). The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches, and the target lesion itself.
- Target Vessel Failure (TVF) [ Time Frame: 9-months ]Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization
- Target Lesion Failure (TLF) [ Time Frame: 9-months ]Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization
- Stent Thrombosis (Definite/Probable) [ Time Frame: 9-months ]The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294748
|Antwerp Hospital, ZNA Middelheim|
|Brussels University Hospital|
|Virga Jesse Ziekenhuis|
|KUL Cardiology Gasthuisberg|
|Jacques Cartier Hospital|
|Claude Galien Hospital|
|St. Antonius Ziekenhuis|
|Auckland City Hospital|
|Auckland, New Zealand|
|Mercy Angiography Unit|
|Auckland, New Zealand|
|Christchurch, New Zealand|
|Dunedin, New Zealand|
|Wellington, New Zealand|
|Sahlgrenska University Hospital|
|Orebro University Hospital|
|Royal Sussex Hosp|
|Brighton, United Kingdom|
|Cambridge, United Kingdom|
|Guy's & St. Thomas'|
|London, United Kingdom|
|London, United Kingdom|
|University Hospital South Manchester|
|Manchester, United Kingdom|
|Norwich, United Kingdom|
|Southampton, United Kingdom|
|Principal Investigator:||William Wijns, MD||Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Aalst (OLV Hospital)|