Health Condition 1: null- Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Cardiovascular Disease
Conditions
Interventions
Intervention1: Everolimus-Eluting Bioresorbable Vascular Scaffold (BVS): Implantation of the device in the treatment of coronary artery disease
Control Intervention1: NIL: NIL
Sponsors
Abbott Cardiovascular Systems Inc
Eligibility
Inclusion criteria
Inclusion criteria: Up to two de novo lesions can be treated, each located in a separate native epicardial vessel. Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is &#8805; 2.0 mm and &#8804; 3.3 mm and target lesion length is &#8804; 28 mm, both assessed by on-line QCA. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of &#8805; 50% and < 100% with a TIMI flow of &#8805; 1. If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, LCX with obtuse marginal and/or ramus intermedius branches and RCA and any of its branches). Percutaneous interventions for lesions in a non-target vessel are allowed if done &#8805; 30 days prior to or if planned to be done 6 months after the index procedure. Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.
Exclusion criteria
Exclusion criteria: •Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and greater than 20% stenosed lesion by visual estimation) arterial or saphenous vein graft. •Lesion(s) involving a bifurcation with side branch vessel greaterthan or equal to 2 mm in diameter and/or ostial lesion greater than 40% stenosed by visual estimation or side branch requiring predilatation. •Total occlusion (TIMI flow 0), prior to wire passing. •Target vessel(s) contains visible thrombus. •Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s). •Subject has received brachytherapy in any epicardial vessel (including side branches).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure)Timepoint: Acute | — |
Secondary
| Measure | Time frame |
|---|---|
| Angiographic OCT subgroup: Aneurysm, thrombus, persisting dissectionTimepoint: 2 years;Angiographic OCT subgroup: Distal LL (distal defined as within 5 mm of tissue distal to scaffold placement)Timepoint: 2 years;Angiographic OCT subgroup: Proximal LL (proximal defined as within 5 mm of tissue proximal to scaffold placement)Timepoint: 2 years;Angiographic OCT subgroup: Treated segment LLTimepoint: 2 years;Angiographic OCT subgroup: Treated site and treated segment % Diameter Stenosis (DS)Timepoint: post-procedure and at 2 years;Angiographic OCT subgroup: Treated site and treated segment Angiographic Binary Restenosis (ABR) rateTimepoint: 2 years;Angiographic OCT subgroup: Treated site and treated segment Minimum Luminal Diameter (MLD)Timepoint: post-procedure and at 2 years;Angiographic OCT subgroup: Treated site Late Loss (LL)Timepoint: 2 years;Cardiac Death (CD)Timepoint: 30, 180 days, and 1, 2, and 3 years.;Ischemia Driven MACE (ID MACE)Timepoint: 30, 180 days, and 1, 2, and 3 years;Ischemia driven Non-Target Vessel Revascularization (ID non- TVR)Timepoint: 30, 180 days and 1, 2, and 3 years;Ischemia Driven Target Lesion Revascularization (ID TLR)Timepoint: 30, 180 days and 1, 2, and 3 years;Ischemia driven Target Vessel Failure (ID TVF)Timepoint: 30, 180 days, and 1, 2, and 3 years;Ischemia Driven Target Vessel Revascularization (ID TVR)Timepoint: 30, 180 days and 1, 2, and 3 years;IVUS OCT subgroup: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete appositionTimepoint: 2 years (if analyzable);IVUS OCT subgroup: Minimum luminal area (MLA)Timepoint: post-procedure and at 2 years;IVUS OCT subgroup: Scaffold area (if analyzable)Timepoint: post-procedure and 2 years;IVUS OCT subgroup: Treated site %Volume Obstruction (VO)Timepoint: 2 years;IVUS OCT subgroup: Vessel areaTimepoint: post-procedure and at 2 years;Lumen areaTimepoint: post-procedure and at 2 years;MSCT subgroup: Descriptive analysis of vascular and scaffold morphologyTim | — |
Countries
India
Contacts
Public ContactVikram Kukkadi
Abbott Vascular Devices, India
Outcome results
None listed