|- candidate number||15886|
|- NTR Number||NTR4318|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-dec-2013|
|- Secondary IDs||none |
|- Public Title||ABSORB BTK|
|- Scientific Title||ABSORB BTK, a prospective single arm registry of the Absorb bioresorbable Everolimus-eluting scaffold in below the knee atherosclerotic arterial lesions
|- hypothesis||The aim of this study is to evaluate the efficacy, and feasibility of the Absorb bioresorbable scaffold in infrapopliteal hemodynamically significant arterial stenoses and occlusions.|
|- Healt Condition(s) or Problem(s) studied||Critical limb ischemia|
|- 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.
− At least 1 outflow artery to the foot distally to the target lesion
− Target vessel diameter ≥ 2.0 and ≤ 3.8mm (instructions for use)
− Successful crossing of the target lesion
|- Exclusion criteria||− PAD 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
− Lesion length > 100mm.
− Aspirin, Clopidogrel, Heparin or Everolimus allergy
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-apr-2014|
|- planned closingdate||1-apr-2016|
|- Target number of participants||80|
|- Interventions||The Absorb everolimus-eluting bioresorbable scaffold will be used in the endovascular treatment of symptomatic tibial atherosclerotic lesions.|
|- Primary outcome||In-stent restenosis at 12 months, defined as lumen narrowing > 50% assessed by angiography|
|- Secondary outcome||− Technical success rate, defined as residual stenosis < 30% |
− Target lesion revascularization (TLR), defined as any endovascular revascularisation of the target lesion.
− Target vessel revascularization (TVR), defined as any endovascular revascularisation of any non-target lesion in the same tibial artery as the target lesion
− Death, defined as any death during follow-up
− Minor amputation, defined as any non-limb amputation, for instance any (partial) amputation of a toe or foot.
− Major amputation, defined as any limb amputation, for instance below-, through-, or above-knee amputation
− Improvement in Rutherford-Becker classification (see appendix B for the Rutherford-Becker classification)
− Wound healing (if applicable), defined as wound closure at the time of the outpatient visit.
|- Timepoints||Follow-up will be obtained at the outpatient clinic 1, 6 and 12 months after the intervention. During follow-up any complications will be registered and physical examination of the treated limb will be performed. Prior to the follow-up visit at 6 and 12 months, all patients will be analysed by treadmill test and duplex of the treated artery. At 12 months of follow-up a diagnostic catheter guided angiography will be performed. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| B. Fioole|
|- CONTACT for SCIENTIFIC QUERIES|| B. Fioole|
|- Sponsor/Initiator ||Dutch Endovascular Alliance (DEAll)|
(Source(s) of Monetary or Material Support)
|Investigator initiated trial ( IIT )|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||16-dec-2013 - 3-jan-2014|