Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorConcept Medical Inc.
About this trial
This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Europe, Australia and Asia. Each site will be capped at 30 maximum subjects recruited.
The main goal of this clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease.
Eligible subjects will be randomised in a 1:1 allocation ratio and stratified by recruiting countries. Each subject will be randomized to receive either:
1. MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or 2. Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 21 years or minimum age (is allowed the inclusion of subjects > 21 years OR adulthood minimum age (depending on the US state regulations)
Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.
Rutherford class 5 to 6 in the target limb with documented WIFI score.
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 30 mm gap between lesions at discretion of investigator. Below the knee arteries are Tibio-peroneal trunk, Peroneal bifurcation, anterior tibial artery, posterior tibial artery and peroneal artery. With documented Distal Run off a maximum of two tibial vessels can be treated in the index procedure. 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.
Disqualifiers
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 lactating, pregnant or planning to become pregnant during the course of the study
Osteomyelitis including and/or proximal to the metatarsal head
Trial design
Design model
Parallel
Treatments tested in this trial
MagicTouch PTA Sirolimus drug coated balloon
DeviceAll patients must first be treated with pre dilatation with a standard balloon angioplasty using any standard balloon catheters at the discretion of the operator. Magic Touch PTA Sirolimus coated balloon catheter is an adjunct treatment that should be used in combination with standard balloon angioplasty. Following successful crossing of wire across the lesion and plain balloon angioplasty of arterial lesion with successful lesion preparation with residual lesion \<30%, subjects will be randomized to receive study device balloon. If patients are assigned to MagicTouch PTA Sirolimus DCB, the Angioplasty of lower limb will be performed with this device in addition to standard balloon angioplasty.
Placebo balloon angioplasty
DeviceFor participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed.
Treatment groups
368 Participants
are divided into 2 treatment groupsGroup A: MagicTouch PTA sirolimus DCBActive comparator 1 intervention
Group B: Placebo balloon angioplastyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary patency at 12 months defined as freedom from Target Vessel Occlusion, Binary Restenosis, Clinically-Driven Target Lesion Revascularization and Major Amputation.
Binary restenosis will be defined as the proportion of subjects with duplex ultrasonography-derived peak systolic velocity ratio of \> 2.0 with correlating factors. If the PSV at the reference area in the vessel is abnormal, the core laboratory will employ the following other criteria to diagnose a stenosis of \> 50%: * Monophasic/ low resistive waveforms (parvus tardus) at the stenotic area or distal to an acoustic shadow * Post-stenotic turbulence distal to the stenosis, along with a decrease in peak systolic velocities Gray scale/ B-mode imaging demonstrates significant plaque with stenosis along with a focal increase in the absolute PSV value. * Occlusion = Absence of color filling and spectral Doppler signal.
Time frame
12 months2
Composite safety endpoint
Proportion of subjects who experienced any of the following: 1. 6-month above ankle major amputation of the index limb, 2. 6-month major re-intervention (i.e., angioplasty of target lesion, new bypass graft, jump/interposition graft, or thrombectomy or thrombolysis) 3. Perioperative (30 day) mortality.
Time frame
6-months for n.1 and n.2; 30 days for n.3Secondary outcomes
1
Secondary Safety endpoint 1
Proportion of device and procedure related death
Time frame
1, 6, 12, 24, 36, 48 and 60 months2
Secondary Safety endpoint 2
Proportion of subjects with death by any cause
Time frame
1, 6, 12, 24, 36, 48 and 60 months3
Secondary Safety endpoint 3
Proportion of subjects with major target limb amputation
Time frame
1, 6, 12, 24, 36, 48 and 60 months4
Secondary Safety endpoint 4
Proportion of subjects with target vessel thrombosis
Time frame
From day 0 to day 14Sponsors and contacts
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Source ClinicalTrials.gov