ABSORB BTK

ABSORB BTK, a prospective single arm registry of the Absorb bioresorbable Everolimus-eluting scaffold in below the knee atherosclerotic arterial lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25502

Enrollment

Registered

2013-12-16

Start date

2014-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical limb ischemia

Interventions

The Absorb everolimus-eluting bioresorbable scaffold will be used in the endovascular treatment of symptomatic tibial atherosclerotic lesions.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
In-stent restenosis at 12 months, defined as lumen narrowing > 50% assessed by angiography	—

Secondary

Measure	Time frame
− 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.	—

Measure

Time frame

− 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.

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Contacts

Public ContactB. Fioole

Maasstadweg 21

fiooleb@maasstadziekenhuis.nl010-2911911

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)