NCT04511247

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
3 countries

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2020Dec 2027

First Submitted

Initial submission to the registry

August 5, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

6.3 years

First QC Date

August 5, 2020

Last Update Submit

June 30, 2025

Conditions

Peripheral Artery DiseaseAtherosclerosisArterial Disease of Legs

Keywords

PADDCBPTASirolimus

Outcome Measures

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)

    6 months

Secondary Outcomes (18)

  • Device and procedure related deaths

    1,6,12 and 24 Months

  • All-cause death

    1,6,12 and 24 Months

  • Major target limb amputation

    6,12 and 24 Months

  • Target vessel thrombosis

    From day 0 to day 14

  • Proportion of subjects who experienced either death at 6 month or major target limb amputation at 6 month or target vessel thrombosis within 14 days.

    Day 0 to day 14, 6 Months

  • +13 more secondary outcomes

Other Outcomes (2)

  • Health-related quality of life

    12 and 24 months

  • Walking impairment

    12 and 24 months

Study Arms (2)

MagicTouch PTA sirolimus drug coated balloon (DCB)

EXPERIMENTAL

MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty

Device: MagicTouch PTA Sirolimus drug coated balloon

Placebo balloon angioplasty

ACTIVE COMPARATOR

Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)

Device: POBA balloon

Interventions

MagicTouch PTA Sirolimus drug coated balloonDEVICE

For 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.

MagicTouch PTA sirolimus drug coated balloon (DCB)
POBA balloonDEVICE

For 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

Placebo balloon angioplasty

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Target vessel has angiographically documented run off to the foot after treatment (ie. without significant stenosis)

You may not qualify if:

  • 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
  • Vulnerable or protected adults
  • Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin
  • Known allergy to sirolimus
  • 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
  • Failure to obtain \<30% residual stenosis in a pre-existing lesion
  • Lesions requiring retrograde access (SAFARI)
  • Highly calcified lesions (Contiguous calcification on both sides of the lesion)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Khoo Teck Puat Hospital

Singapore, Singapore

RECRUITING

National University Hospital

Singapore, Singapore

RECRUITING

Ng Teng Fong General Hospital

Singapore, Singapore

NOT YET RECRUITING

Sengkang General Hospital

Singapore, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Kaoshiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Far Eastern Memorial Hospital

New Taipei City, Taiwan

RECRUITING

Taipei Tzuchi Hospital

New Taipei City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

RECRUITING

Phramongkutklao Hospital

Bangkok, Thailand

RECRUITING

Rajavithi Hospital

Bangkok, Thailand

RECRUITING

Ramathibodi Hospital

Bangkok, Thailand

NOT YET RECRUITING

Siriraj Hospital

Bangkok, Thailand

RECRUITING

Vajira Hospital

Bangkok, Thailand

RECRUITING

Thammasat University Hospital

Pathum Thani, Thailand

RECRUITING

Related Publications (3)

  • Giacoppo D, Cassese S, Harada Y, Colleran R, Michel J, Fusaro M, Kastrati A, Byrne RA. Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials. JACC Cardiovasc Interv. 2016 Aug 22;9(16):1731-42. doi: 10.1016/j.jcin.2016.06.008.

    PMID: 27539695BACKGROUND

  • Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.

    PMID: 27069105BACKGROUND

  • Verheye S, Vrolix M, Kumsars I, Erglis A, Sondore D, Agostoni P, Cornelis K, Janssens L, Maeng M, Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2029-2037. doi: 10.1016/j.jcin.2017.06.021. Epub 2017 Sep 27.

    PMID: 28964764BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Edward Choke

    Sengkang General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Choke

CONTACT

+65 69302164tcchoke@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Eligible subjects will be randomised via a secure online system to a labelled device and to receive either Magic Touch sirolimus drug coated balloon in addition to standard balloon angioplasty or standard balloon angioplasty and placebo balloon.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 13, 2020

Study Start

August 15, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

July 3, 2025

Record last verified: 2025-06

Locations

SG(6)TW(8)TH(6)