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.
ID
Bron
Aandoening
Critical limb ischemia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
In-stent restenosis at 12 months, defined as lumen narrowing > 50% assessed by angiography
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
The Absorb everolimus-eluting bioresorbable scaffold will be used in the endovascular treatment of symptomatic tibial atherosclerotic lesions.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
− 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
− 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4159 |
| NTR-old | NTR4318 |
| Ander register | : none |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |