FUTURE BTK: Randomized Controlled Trial of First SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of Below The Knee Arterial Disease

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Singapore
Khoo Teck Puat Hospital
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Ng Teng Fong General Hospital
NOT_YET_RECRUITING
Singapore
Sengkang General Hospital
RECRUITING
Singapore
Singapore General Hospital
RECRUITING
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Kaoshiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
Taipei Tzuchi Hospital
RECRUITING
New Taipei City
China Medical University Hospital
NOT_YET_RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Shin Kong Wu Ho-Su Memorial Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan
Thailand
Phramongkutklao Hospital
RECRUITING
Bangkok
Rajavithi Hospital
RECRUITING
Bangkok
Ramathibodi Hospital
NOT_YET_RECRUITING
Bangkok
Siriraj Hospital
RECRUITING
Bangkok
Vajira Hospital
RECRUITING
Bangkok
Thammasat University Hospital
RECRUITING
Pathum Thani
Contact Information
Primary
Edward Choke
tcchoke@hotmail.com
+65 69302164
Time Frame
Start Date: 2020-08-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 219
Treatments
Experimental: MagicTouch PTA sirolimus drug coated balloon (DCB)
MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty
Active_comparator: Placebo balloon angioplasty
Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)
Sponsors
Leads: Concept Medical Inc.

This content was sourced from clinicaltrials.gov

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