ABSORB BTK TRIAL A prospective single arm registry of the Absorb Everolimus-eluting bioresorbable vascular scaffold in below the knee atherosclerotic arterial lesions

Phase 3

Recruiting

• Conditions: Critical limb ischemia; vascular disease; 10003184; 10003216

• Registration Number: NL-OMON41072
• Lead Sponsor: Maasstadziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Age >= 18 years
* At least 1 symptomatic de novo or restenotic (after only PTA) atherosclerotic tibial lesion.
* The lesion should be a stenosis of at least 70% or an occlusion
* The maximum length of the lesion is 100mm.
* At least 1 outflow artery to the foot distally to the target lesion, either direct or through collaterals.
* Target vessel diameter >= 2.0 and <= 3.8mm (instructions for use)
* Successful crossing of the target lesion

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
* PAOD Rutherford-Becker classification 1-3 or 6.
* A life expectancy less than 1 year.
* Thrombus within the target lesion
* Multiple stenoses in the tibial target artery
* Acute limb ischemia
* Dissection
* Lesion length > 100mm.
* Aspirin, Clopidogrel, Heparin or Everolimus allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is in-stent restenosis at 12 months, defined as lumen<br /><br>narrowing > 50% assessed by angiography.</p><br>