SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease (FUTURE-BTK)

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    219
  • sponsor
    Concept Medical Inc.
Updated on 23 March 2022
arteriopathy
angiography
stenosis
sirolimus
arterial disease
stenotic
percutaneous transluminal angioplasty
transluminal angioplasty

Summary

This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of below the knee arterial disease.

Description

The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers. Local drug delivery using drug coated balloons (DCB) during angioplasty for PAD can successfully deliver effective local tissue concentrations of anti-proliferative drugs to the lesions in the artery involved in the PAD. This offers the potential for sustained anti-restenotic efficacy.

Randomized trials have shown superiority of Paclitaxel DCBs over just plain-balloon angioplasty for treatment of PAD, and DCB is now considered the standard of care. However, a recent meta-analyses which showed increased mortality at two years in patients treated with paclitaxel DCBs have called into question the safety of paclitaxel based DCBs.

Alternative drugs for DCBs are therefore urgently needed and sirolimus offers an attractive alternative. Compared to Paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety. It has a high transfer rate to the vessel wall and has been shown to effectively inhibit neointimal hyperplasia in the porcine coronary model. In the coronary artery interventions, preliminary clinical studies using Sirolimus DCBs have also shown excellent procedural and 6 month patency.

Details
Condition Peripheral Artery Disease, Atherosclerosis, Arterial Disease of Legs
Treatment MagicTouch PTA Sirolimus drug coated balloon, POBA balloon
Clinical Study IdentifierNCT04511247
SponsorConcept Medical Inc.
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 21 years or minimum age
Rutherford class 4 to 6 in the target limb
Intraoperative Inclusion Criteria
Single or sequential de novo or re-stenotic lesions (stenosis of > 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Below the knee arteries are tibioperoneal trunk, anterior tibial artery, posterior tibial artery and peroneal artery
Inflow free from flow limiting lesions (<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (>50% stenosis) can be included if lesion had been treated successfully (<30% residual stenosis) before or during the index procedure
Target vessel has angiographically documented run off to the foot after treatment (ie. without significant stenosis)

Exclusion Criteria

Comorbid conditions limiting life expectancy ≤ 1 year
Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
Subject is pregnant or planning to become pregnant during the course of the study
Heel gangrene
Prior bypass surgery of target vessel
Planned amputation of the target limb
Previously implanted stent in the target lesion
Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations)
Target vessel has lesions extending beyond the ankle joint
Vulnerable or protected adults
Failure to obtain <30% residual stenosis in a pre-existing lesion
Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin
Lesions requiring retrograde access (SAFARI)
Known allergy to sirolimus
Highly calcified lesions (Contiguous calcification on both sides of the lesion)
Intraoperative Exclusion Criteria
Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)
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