First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)

Study Overview
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Brief Summary
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BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

Official Title
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BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II

Conditions
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Coronary Artery Disease, Coronary Artery Stenosis

Intervention / Treatment
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* Device: Percutaneous Coronary Intervention (DREAMS) stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is > 18 years and < 80 years of age Written subject informed consent available prior to PCI Subjects with stable or unstable angina pectoris or documented silent ischemia Subject eligible for PCI Subject acceptable candidate for coronary artery bypass surgery Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions. Reference vessel diameter between 2.2-3.8 mm by visual estimation Target lesion length ≤ 21 mm by visual estimation Target lesion stenosis by visual estimation, assisted by QCA / IVUS: > 50% - < 100% Eligible for Dual Anti Platelet Therapy (DAPT) Exclusion Criteria: Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study Evidence of myocardial infarction within 72 hours prior to index procedure Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the procedure Unprotected left main coronary artery disease Three-vessel coronary artery disease at time of procedure Thrombus in target vessel Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet Planned interventional treatment of any non-target vessel within 30 days post-procedure Subjects on dialysis Planned intervention of the target vessel within 6-month after the index procedure Ostial target lesion (within 5.0 mm of vessel origin) Target lesion involves a side branch >2.0 mm in diameter Documented left ventricular ejection fraction (LVEF) ≤ 30% Heavily calcified lesion Target lesion is located in or supplied by an arterial or venous bypass graft The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to, rotational atherectomy, cutting balloon etc.) Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention) Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus) Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography Life expectancy less than 1 year Planned surgery or dental surgical procedure within 6 months after index procedure In the investigators opinion subjects will not be able to comply with the follow-up requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Eluting Absorbable Metal Scaffold<br>DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold | Device: Percutaneous Coronary Intervention (DREAMS) stenting<br> <br> * Other names: DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In segment Late Lumen Loss |  | 6 months post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularisation (TLR) |  | 1, 6, 12, 24 and 36 months | 
| Scaffold thrombosis rate |  | 1, 6, 12, 24 and 36 months | 
| In-scaffold and in-segment Binary Restenosis Rate |  | 6 and 12 months | 
| In-scaffold and in-segment Percent Diameter Stenosis |  | 6 and 12 months | 
| Late Lumen Loss in segment |  | 12 months | 
| Late Lumen Loss in scaffold |  | 6 and 12 months | 
| Procedure success | Procedure Success defined as achievement of a final diameter stenosis of <30% by QCA, using any percutaneous method, without the occurrence of death, Q-wave or WHO defined non-Q-wave, or repeat revascularization of the target lesion during the hospital stay. | During the hospital stay to a maximum of the first seven days post index procedure | 
| Device success | Device Success is defined as a final residual diameter stenosis of <30% by QCA, using the assigned device only successful delivery of the scaffold to the target lesion site in the coronary artery appropriate scaffold deployment successful removal of the device safe removal of the device in case of deployment failure | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DREAMS, Drug Eluting Absorbable Metal Scaffold, Scaffold, Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis