Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT04511234
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2020-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 279}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Improvement of quality of life', 'timeFrame': '12 and 24 months', 'description': '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'}, {'measure': 'Walking impairment', 'timeFrame': '12 and 24 months', 'description': 'Mean change from baseline in walking impairment questionnaire score at 12 and 24 months. The score ranges form 0% t 100%, and a higher score means a better outcome'}], 'primaryOutcomes': [{'measure': 'Primary patency at 6 months', 'timeFrame': '6 Months', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Device and procedure related death', 'timeFrame': '1, 6, 12 and 24 Months', 'description': 'Proportion of device and procedure related death'}, {'measure': 'All-cause death', 'timeFrame': '1, 6, 12 and 24 Months', 'description': 'Proportion of subjects died by any cause'}, {'measure': 'Major target limb amputation', 'timeFrame': '1, 6, 12 and 24 Months', 'description': 'Proportion of major target limb amputation'}, {'measure': 'Target vessel thrombosis', 'timeFrame': 'From day 0 to day 14', 'description': 'Proportion of subjects with target vessel thrombosis'}, {'measure': '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', 'timeFrame': 'Day 0 to day 14, 6 Months', 'description': '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'}, {'measure': 'Occurrence of adverse events (AEs), serious AEs and AEs related to device and Occurrence of adverse events (AEs), serious AEs and AEs related to device and procedure', 'timeFrame': 'From Day 0 to 24 Months Follow-up', 'description': 'Occurrence of adverse events (AEs), serious AEs and AEs related to device and Occurrence of adverse events (AEs), serious AEs and AEs related to device and procedure'}, {'measure': 'Procedural Success', 'timeFrame': 'From Day 1 to discharge up to maximum of 30 days', 'description': 'Proportion of subjects with procedural success during hospital stay'}, {'measure': 'Proportion of subjects who are free from clinically-driven Target Lesion Revascularization (TLR)', 'timeFrame': '6,12 and 24 Months', 'description': 'Proportion of subjects who are free from clinically-driven TLR'}, {'measure': 'Proportion of subjects who are free from clinically-driven Target Vessel Revascularization (TVR)', 'timeFrame': '6,12 and 24 Months', 'description': 'Proportion of subjects who are free from clinically-driven Target Vessel Revascularization (TVR)'}, {'measure': 'Primary patency', 'timeFrame': '12 and 24 Months', 'description': 'Primary patency rate at 12 and 24 months'}, {'measure': 'Restenosis', 'timeFrame': '6, 12 and 24 Months', 'description': 'Proportion of subjects with restenosis'}, {'measure': 'Subjects who are free from MAE', 'timeFrame': '6 Months', 'description': 'Proportion of subjects who are free from MAE'}, {'measure': 'Amputation-free survival', 'timeFrame': '6, 12 and 24 Months', 'description': 'Amputation-free survival'}, {'measure': 'Clinical Success', 'timeFrame': '6, 12 and 24 Months', 'description': 'Proportion of subjects with clinical Success at 6, 12 and 24 months, Clinical success is defined as Improvement in Rutherford classification compared to the pre-procedure Rutherford classification'}, {'measure': 'Device success', 'timeFrame': 'Day 1', 'description': 'Proportion of subjects with device success at day 1'}, {'measure': 'Technical success', 'timeFrame': 'Day 1', 'description': 'Proportion of subjects with technical success at day 1'}, {'measure': 'Wound assessment (if any)', 'timeFrame': '1, 6, 12, 24 Months', 'description': 'Wound assessment (if any)'}, {'measure': 'Toe Pressure or ABPI assessment', 'timeFrame': '6, 12, 24 Months', 'description': 'Toe Pressure or ABPI assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PAD', 'DCB', 'PTA', 'Sirolimus'], 'conditions': ['Peripheral Artery Disease', 'Atherosclerosis', 'Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '27539695', 'type': 'BACKGROUND', 'citation': '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': '27069105', 'type': 'BACKGROUND', 'citation': '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': '28964764', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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 superficial and popliteal arterial disease.', 'detailedDescription': 'The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers. Local drug delivery using drug coated balloons (DCB) during angioplasty for PAD can successfully deliver effective local tissue concentrations of anti-proliferative drugs to the lesions in the artery involved in the PAD. This offers the potential for sustained anti-restenotic efficacy.\n\nRandomized 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.\n\nAlternative 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 21 years or minimum age\n2. Rutherford class 3 to 6 in the target limb\n\n Intraoperative Inclusion Criteria\n3. 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\n4. 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.\n5. At least one non-occluded crural vessel (ie. without significant stenosis) with angiographically documented run off to the foot.\n\nExclusion Criteria:\n\n1. Comorbid conditions limiting life expectancy ≤ 1 year\n2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet\n3. Subject is pregnant or planning to become pregnant during the course of the study\n4. Heel gangrene\n5. Prior bypass surgery of target vessel\n6. Planned amputation of the target limb\n7. Previously implanted stent in the target lesion\n8. Vulnerable or protected adults\n9. Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin\n10. Known allergy to sirolimus\n\n Intraoperative Exclusion Criteria\n11. 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)\n12. Failure to obtain \\<30% residual stenosis in a pre-existing lesion\n13. Highly calcific lesions\n14. Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)\n15. Lesions requiring retrograde access (SAFARI)'}, 'identificationModule': {'nctId': 'NCT04511234', 'acronym': 'FUTURE-SFA', 'briefTitle': 'Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Concept Medical Inc.'}, 'officialTitle': 'Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial Femoral Artery and Popliteal Artery Disease', 'orgStudyIdInfo': {'id': 'FUTURE SFA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MagicTouch PTA sirolimus drug coated balloon (DCB)', 'description': 'MagicTouch PTA sirolimus drug coated balloon (DCB) in addition to standard balloon angioplasty', 'interventionNames': ['Device: MagicTouch PTA sirolimus drug coated balloon (DCB)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo balloon angioplasty', 'description': 'Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA)', 'interventionNames': ['Device: POBA standard balloon']}], 'interventions': [{'name': 'MagicTouch PTA sirolimus drug coated balloon (DCB)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['MagicTouch PTA sirolimus drug coated balloon (DCB)']}, {'name': 'POBA standard balloon', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Placebo balloon angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Leong Chuo Ren', 'role': 'CONTACT'}], 'facility': 'Khoo Teck Puat Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Jackie Ho', 'role': 'CONTACT'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'NOT_YET_RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Vikram Vijayan', 'role': 'CONTACT'}], 'facility': 'Ng Teng Fong General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Kalpana Vijaykumar, Dr.', 'role': 'CONTACT'}], 'facility': 'Sengkang General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Chong Tze Tec, A/Prof', 'role': 'CONTACT'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Pua Uei, Dr.', 'role': 'CONTACT'}], 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Po-Chao Hsu, Dr.', 'role': 'CONTACT'}], 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsu Ting Yen, Dr.', 'role': 'CONTACT'}], 'facility': 'Kaoshiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chen Jer-Shen, Dr.', 'role': 'CONTACT'}], 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Huang Hsuan-Li, Dr.', 'role': 'CONTACT'}], 'facility': 'Taipei Tzuchi Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'city': 'Taichung', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chung-Ho Hsu, Dr.', 'role': 'CONTACT'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Lee Jen-Kuang, Dr.', 'role': 'CONTACT'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Lin Chia-Hsun, Dr.', 'role': 'CONTACT'}], 'facility': 'Shin Kong Wu Ho-Su Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chen Chun-Chi, Dr.', 'role': 'CONTACT'}], 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}, {'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Thatchawit Urasuk', 'role': 'CONTACT'}], 'facility': 'Phramongkutklao Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Supachai Chanvitan, Dr.', 'role': 'CONTACT'}], 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'status': 'NOT_YET_RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suthas Horsirimanont, Dr.', 'role': 'CONTACT'}], 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Tossapol Prapassaro', 'role': 'CONTACT'}], 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Wuttichai Saengprakai, Dr.', 'role': 'CONTACT'}], 'facility': 'Vajira Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Pathum Thani', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Boonying Siribumrungwong', 'role': 'CONTACT'}], 'facility': 'Thammasat University Hospital', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}], 'centralContacts': [{'name': 'Edward Choke', 'role': 'CONTACT', 'email': 'tcchoke@hotmail.com', 'phone': '+65 69302164'}], 'overallOfficials': [{'name': 'Edward Choke', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sengkang General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concept Medical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}