coronary heart disease
Conditions
Interventions
Placement of the scaffold study will not differ from a routine stent procedure
(other than the use of a non-CE marked stent). Post-placement of the scaffold
includes IVUS and OCT (this is optional,
Sponsors
Abbott Vascular International
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -) == 50% and = 1. -) Percutaneous interventions for lesions in a non-target vessel are allowed if done >= 30 days 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 > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft. -) Lesion(s) involving a bifurcation with side branch vessel >= 2 mm in diameter, ostial lesion > 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 |
|---|---|
| Acute success (clinical device and clinical procedure); Cardiac Death at 30, 180 days, and 1, 2, and 3 years; Myocardial Infarction at 30, 180 days, and 1, 2, and 3 years; Target Vessel Myocardial Infarction at 30, 180 days, and 1, 2, and 3 years; Ischemia Driven MACE at 30, 180 days, and 1, 2, and 3 years; Ischemia driven Target Vessel Failure at 30, 180 days, and 1, 2, and 3 years; Ischemia Driven Target Lesion Revascularization at 30, 180 days and 1, 2, and 3 years; Ischemia Driven Target Vessel Revascularization at 30, 180 days and 1, 2, and 3 years; Stent thrombosis at 30, 180 days, and 1, 2, and 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive analysis of strut, lesion and vessel morphology post-procedure and at 2 years; Lumen area post-procedure and at 2 years; Minimum luminal area (MLA) post-procedure and at 2 years; In-stent Late Loss (LL) at 2 years; In-segment LL at 2 years; Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement) at 2 years; Distal LL (distal defined as within 5 mm of tissue distal to stent placement) at 2 years; In-stent and in-segment Minimum Luminal Diameter (MLD) post-procedure and at 2 years; In-stent and in-segment % Diameter Stenosis (DS) post-procedure and at 2 years; In-stent and in-segment Angiographic Binary Restenosis (ABR) rate at 2 years; Aneurysm, thrombus, persisting dissection at 2 years; Vessel area post-procedure and at 2 years; In-stent %Volume Obstruction (VO) at 2 years. | — |
Countries
Netherlands
Outcome results
None listed