A Continuation in the Clinical Evaluation of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions

Completed

• Conditions: coronary heart disease; 10011082

• Registration Number: NL-OMON38187
• Lead Sponsor: Abbott Vascular International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

-) =< 2 de novo lesions can be treated, each located in a separate native epicardial vessel.
-) Target lesion(s) must measure <= 28 mm in length.
-) 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 >= 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

-) 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Acute success (clinical device and clinical procedure);<br /><br>Cardiac Death at 30, 180 days, and 1, 2, and 3 years;<br /><br>Myocardial Infarction at 30, 180 days, and 1, 2, and 3 years;<br /><br>Target Vessel Myocardial Infarction at 30, 180 days, and 1, 2, and 3 years;<br /><br>Ischemia Driven MACE at 30, 180 days, and 1, 2, and 3 years;<br /><br>Ischemia driven Target Vessel Failure at 30, 180 days, and 1, 2, and 3 years;<br /><br>Ischemia Driven Target Lesion Revascularization at 30, 180 days and 1, 2, and 3<br /><br>years;<br /><br>Ischemia Driven Target Vessel Revascularization at 30, 180 days and 1, 2, and 3<br /><br>years;<br /><br>Stent thrombosis at 30, 180 days, and 1, 2, and 3 years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Descriptive analysis of strut, lesion and vessel morphology post-procedure and<br /><br>at 2 years;<br /><br>Lumen area post-procedure and at 2 years;<br /><br>Minimum luminal area (MLA) post-procedure and at 2 years;<br /><br>In-stent Late Loss (LL) at 2 years;<br /><br>In-segment LL at 2 years;<br /><br>Proximal LL (proximal defined as within 5 mm of tissue proximal to stent<br /><br>placement) at 2 years;<br /><br>Distal LL (distal defined as within 5 mm of tissue distal to stent placement)<br /><br>at 2 years;<br /><br>In-stent and in-segment Minimum Luminal Diameter (MLD) post-procedure and at 2<br /><br>years;<br /><br>In-stent and in-segment % Diameter Stenosis (DS) post-procedure and at 2 years;<br /><br>In-stent and in-segment Angiographic Binary Restenosis (ABR) rate at 2 years;<br /><br>Aneurysm, thrombus, persisting dissection at 2 years;<br /><br>Vessel area post-procedure and at 2 years;<br /><br>In-stent %Volume Obstruction (VO) at 2 years.</p><br>