ABSORB BTK
- Conditions
- Critical limb ischemia
- Registration Number
- NL-OMON25502
- Lead Sponsor
- Dutch Endovascular Alliance (DEAll)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion 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 with a maximum length of 100mm.
Exclusion Criteria
−PAD Rutherford-Becker classification 1-3 or 6.
−A life expectancy less than 1 year.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In-stent restenosis at 12 months, defined as lumen narrowing > 50% assessed by angiography
- Secondary Outcome Measures
Name Time Method −Technical success rate, defined as residual stenosis < 30% <br /><br>−Target lesion revascularization (TLR), defined as any endovascular revascularisation of the target lesion.<br /><br>−Target vessel revascularization (TVR), defined as any endovascular revascularisation of any non-target lesion in the same tibial artery as the target lesion<br /><br>−Death, defined as any death during follow-up<br /><br>−Minor amputation, defined as any non-limb amputation, for instance any (partial) amputation of a toe or foot.<br /><br>−Major amputation, defined as any limb amputation, for instance below-, through-, or above-knee amputation<br /><br>−Improvement in Rutherford-Becker classification (see appendix B for the Rutherford-Becker classification)<br /><br>−Wound healing (if applicable), defined as wound closure at the time of the outpatient visit.<br /><br>