Table 2 Summary of clinical trials for lower extremity endovascular interventions for the treatment of PAD
From: Diversity in randomized clinical trials for peripheral artery disease: a systematic review
Trial Name and Clinical Trial ID No. | Study description | Type of randomiz-ation | Trial phase | Trial blinding | Interv-ention model | Study location | Study sponsor | Recruitment status |
|---|---|---|---|---|---|---|---|---|
EMINENT NCT02921230 | The EMINENT study is a prospective, multi-center study confirming the superior effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries | 2:1 randomiz-ation | N/A | Single (Participant) | Parallel Assign-ment | Geographically spread (Ulsan, Seoul, Pusan, Gyeonggi-do, Jeonju, Bucheon, etc.) Hospital type (University hospitals, hospitals, and VA hospitals) | Boston Scientific Corporation | Active, not recruiting |
FIRESTEP NCT04700371 | The trial investigates the impact of two different self-expandable nitinol-based stent designs on the target lesion restenosis rate in femoro-popliteal arteries | NR | N/A | None (Open Label) | Parallel Assign-ment | NR- appears single center urban | Kantonsspital Aarau | Not yet recruiting |
DCB-SFA NCT02648334 | This study evaluates the safety and effectiveness of PTA using DCB for the treatment of SFA/PPA artery in PAD patients | NR | N/A | None (Open Label) | Parallel Assign-ment | Geographically spread (Ulsan, Seoul, Pusan, Gyeonggi-do, Jeonju, Bucheon, etc.) Hospital type (University hospitals, hospitals, and VA hospitals) | Seung-Whan Lee, M.D., Ph.D., Asan Medical Center | Unknown |
The PAVENST Trial NCT02212470 | To evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment | NR | Phase 4 | Double (Participant, Outcomes Assessor) | Parallel Assign-ment | Urban hospital | Instituto Dante Pazzanese de Cardiologia Medtronic | Completed |
ILLUMENATE-BTK NCT03175744 | To demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of BTK arteries | NR | N/A | Single (Participant) | Parallel Assign-ment | Multiple countries, several states, and urban | Spectranetics Corporation Philips Healthcare | Suspended |
AcoArt II/BTK China NCT02137577 | To determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery | NR | N/A | Single (Outcomes Assessor) | Parallel Assign-ment | Geographically spread in China (Dalian, Beijing Shanghai, Guangzhou, Shenyang, Shijiazhuang, and Tianjin) | Acotec Scientific Co., Ltd | Completed |
BIOLUX P-II NCT01867736 | To assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the infrapopliteal arteries | 1:1 randomiz-ation | N/A | None (Open Label) | Parallel Assign-ment | Hospital and urban mix Geographic (Austria, Belgium [ Bonheiden and Dendermonde], and Germany [ Bad Krozingen, Berlin, and Leipzig]) University and hospital locations | Biotronik AG | Completed |
LIMES NCT04772300 | This trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with infrapopliteal artery disease | 1:1 randomiz-ation | N/A | Double (Participant, Outcomes Assessor) | Parallel Assign-ment | Several study locations across Austria and Germany | Jena University Hospital Concept Medical Inc VascuScience GmbH CoreLab Black Forest Center for Clinical Studies, University Hospital Jena | Recruiting |
SIRONA NCT04475783 | This trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease | 1:1 randomiz-ation | N/A | None (Open Label) | Parallel Assign-ment | Multiple sites across Germany | Jena University Hospital Concept Medical Inc Vascuscience CoreLab Black Forest Center for Clinical Studies Jena | Active, not recruiting |
SINGA-PACLI NCT02129634 | To study the results of DEB-PTA compared to conventional balloon CB-PTA for the treatment of infragenicular lesions in patients with CLI | 1:1 randomiz-ation | N/A | Double (Participant, Outcomes Assessor) | Parallel Assign-ment | Urban | Singapore General Hospital Tan Tock Seng Hospital Duke-NUS Graduate Medical School Singapore Clinical Research Institute | Completed |
SirPAD NCT04238546 | To investigate whether the use of sirolimus-coated balloon catheters in patients with PAD of the femoro-popliteal or BTK segment is not inferior to that of uncoated balloon catheters for major clinical outcomes (unplanned major amputation, target limb re-vascularization) | NR | Phase 3 | None (Open Label) | Parallel Assign-ment | Urban hospitals | Nils Kucher | Recruiting |
The Chocolate Touch Study NCT02924857 | To show sufficient safety and effectiveness of the Chocolate Touchâ„¢ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States | 1:1 randomiz-ation | N/A | Single (Participant) | Parallel Assign-ment | Urban Several states across the US Mix of University, hospital, and research institutes Multiple countries (US, Austria, Germany, New Zealand) | TriReme Medical, LLC | Active, not recruiting |
ILLUMENATE NCT01858428 | To evaluate the safety and efficacy of a Paclitaxel-coated PTA catheter in the treatment of patients with PAD | 2:1 randomiz-ation | N/A | Single (Participant) | Parallel Assign-ment | Across multiple locations (25) and states in the United States (42) and Austria (2) | Spectranetics Corporation | Completed |
NR NCT05415995 | To compare the efficacy and safety of DCB (Zylox-Tonbridge) with a similar balloon catheter produced by Acotec | NR | N/A | None (Open Label) | Parallel Assign-ment | Uncertain | Zhejiang Zylox Medical Device Co., Ltd | Recruiting |
TIGRIS NCT01576055 | To evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, a 24Â cm in length, in the superficial femoral and proximal popliteal arteries of patients with symptomatic PAD | 3:1 randomiz-ation | N/A | None (Open Label) | Parallel Assign-ment | Geographic spread (several states), urban primarily | W.L.Gore & Associates | Completed |
SAVAL NCT03551496 | To demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. PTA | 2:1 randomiz-ation | Phase 3 | Single (Outcomes Assessor) | Parallel Assign-ment | Urban—uncertain | Boston Scientific Corporation | Active, not recruiting |
HEROES-DCB NCT02812966 | Investigators hypothesize in patients presenting with significant PAD with clinical indications for treatment with angioplasty, there will be a difference in 12Â month patency between the subjects with Lutonix 035 DCB PTA Catheter and IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter | NR | N/A | None (Open Label) | Parallel Assign-ment | Urban and uncertain | Advocate Health Care | Unknown |
ILLUMENATE EU NCT01858363 | To demonstrate the safety and effectiveness of the CVI Paclitaxel-coated PTA balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the SFA and popliteal arteries | 3:1 randomiz-ation | N/A | Single (Participant) | Parallel Assign-ment | NR | Spectranetics Corporation | Completed |
NR NCT02965677 | To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery | 1:1 randomiz-ation | N/A | None (Open Label) | Parallel Assign-ment | Hospitals, urban | ZhuHai Cardionovum Medical Device Co., Ltd | Unknown |
Acoart SCB SFA NCT04982367 | To compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis | NR | N/A | None (Open Label) | Parallel Assign-ment | Single urban hospital locatin | Acotec Scientific Co., Ltd | Recruiting |
Lutonix BTK Trial NCT01870401 | To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries | 2:1 randomiz-ation | N/A | Single (Participant) | Parallel Assign-ment | Urban hospitals primarily | C. R. Bard | Completed |
BEST SFA Pilot Study NCT03776799 | To compare the efficacy and safety of a stent-avoiding (using DCBs) versus a stent-preferred (using drug eluting or interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II (for the Management of PAD | 1:1 randomiz-ation | N/A | None (Open Label) | Parallel Assig-nment | NR | University of Leipzig | Active, not recruiting |
COMPARE NCT02701543 | To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in SFA/PPA artery in PAD patients with Rutherford class 2–4 | 1:1 randomiz-ation | N/A | None (Open Label) | Parallel Assign-ment | Unsure | University of Leipzig | Active, not recruiting |
NR NCT02962232 | To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation catheter compared to the PTA catheter in treatment of stenosis or occlusion in BTK artery | 1:1 randomi-zation | N/A | None (Open Label) | Parallel Assign-ment | Unclear—mostly urban | ZhuHai Cardionovum Medical Device Co., Ltd | Unknown |
NR NCT03121430 | To evaluate the safety and efficacy of drug eluting peripheral vascular stent system for the treatment of SFA stenosis and / or occlusion | 1:1 randomiz-ation | N/A | Single (participant) | Parallel Assign-ment | Urban Hospital | Zhejiang Zylox Medical Device Co., Ltd. and Guangzhou Osmunda Medical Device Technology, Inc., Ltd | Unknown |
SFA ISR NCT02063672 | To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of SFA in-stent restenosis (ISR) | NR | N/A | Single (Outcomes Assessor) | Parallel Assign-ment | Mix of urban and suburban; hospitals, medical centers, academic institutions, and research foundations | C. R. Bard | Completed |
SELUTION4SFA Trial NCT05132361 | To demonstrate the safety and efficacy of the SELUTION SLR 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of PAD in the SFA/PPA artery | NR | N/A | Single (Participant) | Parallel Assign-ment | N/A | M.A. Med Alliance S.A. and NAMSA | Not yet recruiting |
NR NCT05055297 | To demonstrate superior efficacy and equivalent safety of the SELUTION SLR DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of PAD in the BTK arteries in CLTI patients | NR | N/A | Single (Participant) | Parallel Assign-ment | N/A | M.A. Med Alliance S.A | Recruiting |
ZILVERPASS NCT01952457 | To evaluate the early and mid-term outcome (after 6 and 12Â months) and the long-term (up to 24Â months) outcome of the Zilver PTX paclitaxel-eluting stent (Cook) versus bypass surgery for the treatment of TASC C&D femoropopliteal lesions | 1:1 randomiz-ation | Phase 4 | None (Open Label) | Parallel Assign-ment | Hospital located in different geographic areas in Belgium | Flanders Medical Research Program | Active, not recruiting |
BIOPACT-RCT NCT03884257 | To investigate the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux DCB | 1:1 randomiz-ation | N/A | Single (Participant) | Parallel Assign-ment | Unsure—urban hospitals I think | ID3 Medical | Active, not recruiting |
RANGER II SFA NCT03064126 | To evaluate the safety and effectiveness of the Ranger Paclitaxel Coated Balloon for treating lesions located in the (SFA/PPA) arteries | 3:1 randomiz-ation | Phase 3 | Single (participant) | Parallel Assign-ment | Community/city hospitals Multiple countries and states Mix of research institutes, Universities, and Hospitals | Boston Scientific Corporation | Active, not recruiting |
NR ChiCTR1900023619 | To evaluate the efficacy and safety of DCB for treatment of long femoropopliteal Artery disease compared to standard balloon | NR | N/A | NR | Parallel Assign-ment | Single hospital (Tertiary A Hospital) | Beijing Chaoyang Hospital, Capital Medical University | Not yet recruiting |
IMPERIAL NCT02574481 | To evaluate the safety and effectiveness of Eluvia drug-eluting Vascular Stent System for treating SFA and/or PPA lesions up to 140Â mm in length | 2:1 randomiz-ation | N/A | Single (Participant) | Parallel Assign-ment | Mix of countries Diverse states across the study locations Mix of community hospitals, academic hospitals, university hospitals, and referral centers | Boston Scientific Corporation | Completed |
TRANSCEND NCT03241459 | To demonstrate the safety and efficacy of the SurVeil DCB for treatment of subjects with symptomatic PAD due to stenosis of the femoral and/or popliteal arteries | NR | N/A | Single (Participant) | Parallel Assign-ment | Geographic locations US (28 states); Austria (1), Australia (1), Belgium (2), Czechia (2), Germany (4), Italy (1), Latvia (1), and New Zealand (1) Mix of University, research centers, and hospitals | SurModics, Inc | Active, not recruiting |
REAL PTX NCT01728441 | To compare paclitaxel-eluting stents to paclitaxel-eluting balloons for treating symptomatic PAD of the femoropopliteal artery | NR | N/A | None (Open Label) | Parallel Assign-ment | Urban University (1) Hospital (4) By province: Germany (Leipzig, Hamburg, and Bad Krozingen) Beligum (Bonheiden and Dendermonde) | Provascular GmbH William Cook Europe | Completed |
Trial Name and Clinical Trial ID No. | Study start date | Study end date | Estimated enrollment of participants | Actual enrollment of participants | Sex of PI* | Country of PI* | Device name of intervention | Device name of comparator |
|---|---|---|---|---|---|---|---|---|
EMINENT NCT02921230 | 2016 | 2025 | N/A | 775 | Male | Germany and France | Eluvia Drug-Eluting Vascular Stent System (Boston Scientific) | Innova vascular self-expanding stent system (Boston Scientific)/BMS |
FIRESTEP NCT04700371 | 2022 | 2024 | 110 | N/A | Male | Switzerland | Name not reported (BMS) | NR (BMS) |
DCB-SFA NCT02648334 | 2016 | 2021 | 1080 | N/A | Unknown | Republic of Korea | Lutonix DCB | IN.PACT (DCB) |
The PAVENST Trial NCT02212470 | 2014 | 2019 | N/A | 85 | Male | Brazil | Admiral In.Pact (Medtronic) | Complete SE (Medtronic)/BMS |
ILLUMENATE-BTK NCT03175744 | 2017 | 2025 | 354 | N/A | Male | USA | Stellarex DCB | Not reported/ PTA balloon catheter |
AcoArt II/BTK China NCT02137577 | 2014 | 2020 | N/A | 120 | Male | China | Litos/Tulip | Amphirion Deep/PTA balloon catheter |
BIOLUX P-II NCT01867736 | 2012 | 2014 | N/A | 72 | Male | Germany | Passeo-18 Lux (Biotronik) | Uncoated Passeo-18 PTA balloon catheter |
LIMES NCT04772300 | 2022 | 2027 | 230 | N/A | Male | Germany | Magic Touch PTA (Concept Medical) | Device name reported/PTA balloon catheter |
SIRONA NCT04475783 | 2021 | 2027 | 478 | N/A | Male | Germany | IN.PACT Admiral (Medtronic) Luminor (iVascular) Lutonix (BD BARD Peripheral Vascular) Orchid (Acotec Scientific Co., Ltd.) Ranger (Boston Scientific,) SeQuent Please OTW (B. Braun Melsungen AG) Stellarex (Philips) | NR(Commercially available paclitaxel-coated balloon types) |
SINGA-PACLI NCT02129634 | 2013 | 2018 | N/A | 136 | Male | Singapore | Name not reported (PTA balloon catheter) | Device name not reported/DCB |
SirPAD NCT04238546 | 2020 | 2028 | 1,200 | N/A | Male | Switzerland | Magic Touch PTA (Concept Medical) | Device name not reported/PTA balloon catheter |
The Chocolate Touch Study NCT02924857 | 2017 | 2026 | 585 | 313 | Male | USA and Germany | Chocolate Touch | Lutonix Drug Coated Balloon |
ILLUMENATE NCT01858428 | 2013 | 2018 | N/A | 300 | Male | USA | EverCross | EverCross 0.035 PTA + Paclitaxel |
NR NCT05415995 | 2022 | 2024 | 202 | N/A | Unknown | China | Zylox-tonbridge | Acotec |
TIGRIS NCT01576055 | 2012 | 2017 | N/A | 267 | Male | USA | TIGRIS Vascular Stent (Gore) | Life Stent (Bard) |
SAVAL NCT03551496 | 2018 | 2029 | 301 | N/A | Male | USA | SAVAL | Device name not reported/ PTA balloon catheter |
HEROES-DCB NCT02812966 | 2016 | 2019 | 250 | N/A | Male | USA | Lutonix DCB | IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter (Medtronic) |
ILLUMENATE EU NCT01858363 | 2012 | 2020 | N/A | 294 | Male | Germany | CVI Paclitaxel-coated PTA Balloon Catheter | Bare PTA Balloon Catheter |
NR NCT02965677 | 2016 | 2021 | 172 | N/A | Male | China | LEGFLOW OTW | Admiral Xtreme |
Acoart SCB SFA NCT04982367 | 2021 | 2024 | 166 | N/A | Male | China | Sirolimus-eluting balloon catheter (Acotec) | Paclitaxel-eluting balloon cathete |
Lutonix BTK Trial NCT01870401 | 2013 | 2021 | N/A | 442 | Male | USA | Lutonix DCB | Standard uncoated PTA Catheter |
BEST SFA Pilot Study NCT03776799 | 2019 | 2026 | 120 | N/A | Male | Germany | NR | Device name not reported/DCS |
COMPARE NCT02701543 | 2015 | 2023 | 414 | N/A | Male | Germany | Ranger DEB (Boston Scientific) | In Pact DEB (Medtronic) |
NR NCT02962232 | 2016 | 2020 | 172 | N/A | Unknown | China | LEGFLOW OTW | AMPHIRION DEEP |
NR NCT03121430 | 2018 | 2021 | 138 | N/A | Unknown | China | NR | Cordis Corporation |
SFA ISR NCT02063672 | 2014 | 2019 | N/A | 82 | Male | USA | Lutonix DCB | Standard Uncoated Balloon Angioplasty Catheter |
SELUTION4SFA Trial NCT05132361 | 2022 | 2028 | 300 | N/A | Male; Female | Switzerland | SELUTION SLR (MedAlliance) | Uncoated PTA |
NR NCT05055297 | 2022 | 2028 | 377 | N/A | Male | Germany | SELUTION SLR (MedAlliance) | Plain (Uncoated) Balloon Angioplasty (PTA) |
ZILVERPASS NCT01952457 | 2014 | 2019 | 220 | N/A | Male | Belgium | Zilver PTX stent (Cook) | Dacron or expanded polytetrafluoroethylene |
BIOPACT-RCT NCT03884257 | 2020 | 2026 | N/A | 302 | Male | Belgium | Passeo-18 Lux (Biotronik) / PTA balloon catheter | IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter (Medtronic) |
RANGER II SFA NCT03064126 | 2017 | 2023 | 446 | 440 | Male | USA and Germany | Ranger DEB (Boston Scientific) | Device name not reported/ PTA balloon catheter |
NR ChiCTR1900023619 | 2019 | NR | 72 | 36 | Male | China | Orchid DCB (Acotec Scientific) | Admiral Xtreme PTA balloon catheter |
IMPERIAL NCT02574481 | 2015 | 2022 | N/A | 524 | Male | USA and Germany | Eluvia Drug-Eluting Vascular Stent System (Boston Scientific) | Zilver PTX DES |
TRANSCEND NCT03241459 | 2017 | 2024 | 446 | N/A | Male; Female | USA | Surmodics SurVeil DCB | Medtronic IN.PACT Admiral DCB |
REAL PTX NCT01728441 | 2012 | 2014 | N/A | 150 | Male | Germany | Zilver PTX stent (Cook) / DES | In.Pact Admiral or In.Pact Pacific (Medtronic) Lutonnix (C.R. Bard) |