No registrations found.
ID
Source
Health condition
Critical limb ischemia
Sponsors and support
Intervention
Outcome measures
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.
Background summary
N/A
Study objective
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.
Study design
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.
Intervention
The Absorb everolimus-eluting bioresorbable scaffold will be used in the endovascular treatment of symptomatic tibial atherosclerotic lesions.
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
− Dissection
− Lesion length > 100mm.
− Aspirin, Clopidogrel, Heparin or Everolimus allergy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4159 |
| NTR-old | NTR4318 |
| Other | : none |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |