ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation

Study Overview
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Brief Summary
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Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x 18 mm BVS EECSS containing 98 microgramme per cm² of surface area.

Detailed Description
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Prospective, open-labeled Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm and lesion length ≥ 8 mm receiving a single 3.0 x 12 mm BVS Everolimus Eluting CSS containing 98 microgramme per cm² of surface area. Lesion length will be expanded to≥ 14 mm in length by visual estimation when 3.0 x 18 mm stent is available. Angiographic, Intravascular Ultrasound (IVUS), Intravascular Ultrasound- virtual histology (IVUS-VH) and Palpography follow-up will be carried out in all patients at 180 days and 2 years following the index procedure Optical Coherence Tomography (OCT) follow-up at 180 days and 2 years will be carried out in a subset of up to 10 patients in Cohorts A and B respectively who are enrolled in pre-determined clinical site(s) Multi-slice Spiral Computed Tomography (MSCT) is an optional procedure which may be carried out at 18 months post procedure and again between 4 and 5 year follow up. Additionally, coronary vasomotion test may be done at 2 years post procedure Single patient Cohort of 30. Pipeline products. Currently in development at Abbott Vascular. Not available for sale.

Official Title
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Bioabsorbable Vascular Solutions First in Man Clinical Investigation: A Clinical Evaluation of the Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With Single de Novo Native Coronary Artery Lesions

Conditions
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Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Intervention / Treatment
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* Device: Bioabsorbable Everolimus Eluting Coronary Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Target lesion must be located in a native epicardial vessel with visually estimated nominal vessel diameter of 3.0 mm Target lesion must measure less/equal 8 mm in length by visual estimation for 3.0 x 12 mm, expanded to less/equal 14 mm in length by visual estimation when 3.0 x 18 mm stent is available The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% with a TIMI flow of greater/equal 1 Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done more/equal 90 days prior to or if planned to be done 6 months after the index procedure Non-Clinical Investigation, percutaneous intervention for lesions in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure Exclusion Criteria: Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft Lesion involving a bifurcation greater/equal 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation Total occlusion (TIMI flow 0), prior to wire passing The target vessel contains visible thrombus Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion Patient has received brachytherapy in any epicardial vessel (including side branches)

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System | Device: Bioabsorbable Everolimus Eluting Coronary Stent<br>* Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease<br>* Other names: BVS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia Driven MACE |  | at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; | 
| Ischemia driven Target Vessel Failure (TVF) |  | at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; | 
| Acute success (clinical device and clinical procedure) |  | Acute | 
| Ischemia Driven Target Lesion Revascularization (TLR) |  | at 30, 180, 270 days and 1, 2, 3, 4, 5 years; | 
| Ischemia Driven Target Vessel Revascularization (TVR) |  | at 30, 180, 270 days and 1, 2, 3, 4, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Late Loss(LL) |  | at 180 days and 2 years | 
| In-segment LL |  | at 180 days and 2 years | 
| Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement) |  | at 180 days and 2 years | 
| Distal LL (distal defined as within 5 mm of tissue distal to stent placement) |  | at 180 days and 2 years | 
| In-stent and in-segment Angiographic Binary Restenosis (ABR) rate |  | at 180 days and 2 years | 
| In-stent % Volume Obstruction (VO) |  | at 180 days and 2 years | 
| Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection |  | at 180 days and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioabsorbable, Coronary Stent, Everolimus, drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis