SirolimUs CoaTed Balloon for 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 21 years or minimum age
Rutherford class 4 to 6 in the target limb
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.
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 pregnant or planning to become pregnant during the course of the study
Heel gangrene
Trial design
Design model
Parallel
Treatments tested in this trial
MagicTouch PTA Sirolimus drug coated balloon
DeviceFor participants randomised to MagicTouch PTA sirolimus DCB, following successful plain balloon angioplasty of the arterial lesion (defined as \<30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), MagicTouch sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
POBA balloon
DeviceFor participants randomised to the standard balloon angioplasty group, a placebo standard balloon which is identical to the SCB will also be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty
Treatment groups
219 Participants
are divided into 2 treatment groupsGroup A: MagicTouch PTA sirolimus drug coated balloon (DCB)Experimental treatment 1 intervention
Group B: Placebo balloon angioplastyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary patency at 6 months
Primary patency rate at 6 months defined as proportion of subjects with duplex ultrasonography-derived peak systolic velocity ratio of ≤ 2.4 (in absence of target lesion revascularisation)
Time frame
6 monthsSecondary outcomes
1
Device and procedure related deaths
Proportion of device and procedure related deaths
Time frame
1,6,12 and 24 Months2
All-cause death
Proportion of subjects died by any-cause
Time frame
1,6,12 and 24 Months3
Major target limb amputation
Proportion of subjects with major target limb amputation
Time frame
6,12 and 24 Months4
Target vessel thrombosis
Proportion of subjects with target vessel thrombosis
Time frame
From day 0 to day 14Other outcomes
1
Health-related quality of life
Mean change from baseline in EuroQol-5Dimensions (EQ-5D) health-related quality of life questionnaire score at 12 and 24 months. The score ranges from 0 to 1, and a higher score means a better outcome
Time frame
12 and 24 months2
Walking impairment
Mean change from baseline in walking impairment questionnaire score at 12 and 24 months. The score ranges from 0% to 100% and a higher score means a better outcome
Time frame
12 and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov