search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


ABSORB BTK


- candidate number15886
- NTR NumberNTR4318
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2013
- Secondary IDsnone 
- Public TitleABSORB BTK
- Scientific TitleABSORB BTK, a prospective single arm registry of the Absorb bioresorbable Everolimus-eluting scaffold in below the knee atherosclerotic arterial lesions
- ACRONYM
- hypothesisThe 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) studiedCritical 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
− Dissection
− Lesion length > 100mm.
− Aspirin, Clopidogrel, Heparin or Everolimus allergy
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-apr-2016
- Target number of participants80
- InterventionsThe Absorb everolimus-eluting bioresorbable scaffold will be used in the endovascular treatment of symptomatic tibial atherosclerotic lesions.
- Primary outcomeIn-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.
- TimepointsFollow-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 siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES B. Fioole
- CONTACT for SCIENTIFIC QUERIES B. Fioole
- Sponsor/Initiator Dutch Endovascular Alliance (DEAll)
- Funding
(Source(s) of Monetary or Material Support)
Investigator initiated trial ( IIT )
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD16-dec-2013 - 3-jan-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl