Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: MiStent DES
* Device: Endeavor DES


Participation Criteria
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Eligibility Criteria
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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. Patient capable of providing informed consent and is willing to comply with all study requirements. 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; Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L); Platelet count <100,000 cells/mm³ or >700,000 cells/mm³; White blood cell count <3,000 cells/mm3; Hepatic disease; Heart transplant recipient; Known contraindication to DAPT; 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); Life expectancy less than 12 months; Any major medical condition that may interfere with participation in this study; 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; 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; 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; Patient previously treated at any time with brachytherapy; 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; Prior PCI of a non-target vessel must be at least 14 days prior to study enrollment; The intent to direct stent the target lesion; 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: Located within the target vessel; Located within a bypass graft ; Left main location; Chronic total occlusion Involves a complex bifurcation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MiStent DES<br>The MiStent SES is a sirolimus-eluting absorbable polymer stent for coronary artery revascularization. | Device: MiStent DES<br>* The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).<br>|
| Active Comparator: Endeavor DES<br>The Endeavor DES is an everolimus-eluting durable polymer stent for coronary artery revascularization. | Device: Endeavor DES<br>* The Endeavor is a device/drug combination comprised of two components; a stent and a drug product (everolimus within a durable polymer coating).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-Stent Late Lumen Loss | 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 | 9 months | 
| Major Adverse Cardiac Events (MACE) | 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. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only. | 8 hours | 
| Lesion Success | Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method. | 8 hours | 
| Procedural Success | 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. | 8 hours | 
| Total Mortality |  | 9-months | 
| Total Myocardial Infarct (MI) | 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. | 9-months | 
| Clinically-driven Target Lesion Revascularization (TVR) | 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. | 9-months | 
| Target Vessel Failure (TVF) | Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization | 9-months | 
| Target Lesion Failure (TLF) | Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization | 9-months | 
| Stent Thrombosis (Definite/Probable) | 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 | 9-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Drug-eluting Stent, Sirolimus