Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
NCT ID: NCT04511234
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
279 participants
INTERVENTIONAL
2020-09-08
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MagicTouch PTA sirolimus drug coated balloon (DCB)
MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty
MagicTouch PTA sirolimus drug coated balloon (DCB)
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 PTA sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
Placebo balloon angioplasty
Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)
POBA standard balloon
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.
Interventions
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MagicTouch PTA sirolimus drug coated balloon (DCB)
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 PTA sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
POBA standard balloon
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.
Eligibility Criteria
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Inclusion Criteria
2. Rutherford class 3 to 6 in the target limb
3. Single or sequential de novo or re-stenotic lesions (stenosis of \> 50% or occlusions) from 2 to 20cm in the femoropopliteal arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Femoropopliteal arteries are superficial femoral artery, popliteal artery P1 and P2
4. 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.
5. At least one non-occluded crural vessel (ie. without significant stenosis) with angiographically documented run off to the foot.
Exclusion Criteria
2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
3. Subject is pregnant or planning to become pregnant during the course of the study
4. Heel gangrene
5. Prior bypass surgery of target vessel
6. Planned amputation of the target limb
7. Previously implanted stent in the target lesion
8. Vulnerable or protected adults
9. Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin
10. Known allergy to sirolimus
11. 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)
12. Failure to obtain \<30% residual stenosis in a pre-existing lesion
13. Highly calcific lesions
14. Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)
15. Lesions requiring retrograde access (SAFARI)
21 Years
ALL
No
Sponsors
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Concept Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Choke
Role: PRINCIPAL_INVESTIGATOR
Sengkang General Hospital
Locations
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Khoo Teck Puat Hospital
Singapore, , Singapore
National University Hospital
Singapore, , Singapore
Ng Teng Fong General Hospital
Singapore, , Singapore
Sengkang General Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaoshiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taipei Tzuchi Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Phramongkutklao Hospital
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Vajira Hospital
Bangkok, , Thailand
Thammasat University Hospital
Pathum Thani, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Leong Chuo Ren
Role: primary
Jackie Ho
Role: primary
Vikram Vijayan
Role: primary
Kalpana Vijaykumar, Dr.
Role: primary
Chong Tze Tec, A/Prof
Role: primary
Pua Uei, Dr.
Role: primary
Po-Chao Hsu, Dr.
Role: primary
Hsu Ting Yen, Dr.
Role: primary
Chen Jer-Shen, Dr.
Role: primary
Huang Hsuan-Li, Dr.
Role: primary
Chung-Ho Hsu, Dr.
Role: primary
Lee Jen-Kuang, Dr.
Role: primary
Lin Chia-Hsun, Dr.
Role: primary
Chen Chun-Chi, Dr.
Role: primary
Thatchawit Urasuk
Role: primary
Supachai Chanvitan, Dr.
Role: primary
Suthas Horsirimanont, Dr.
Role: primary
Tossapol Prapassaro
Role: primary
Wuttichai Saengprakai, Dr.
Role: primary
Boonying Siribumrungwong
Role: primary
References
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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.
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.
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.
Other Identifiers
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FUTURE SFA
Identifier Type: -
Identifier Source: org_study_id
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