Clinical trials: Drug-coated Balloon
Arteriovenous Fistula
Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae
This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating…
- Trial name
- NCT02440022
- Testing
- Lutonix DCB, Standard Balloon Angioplasty Catheter, Percutaneous Transluminal Angiography
- Where
- 23 sites in United States
- Volunteers
- 285 people
- Sponsor
- C. R. Bard
Peripheral Artery Disease, Femoropopliteal Artery Occlusion
LEVANT 2 Safety Registry
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in…
- Conditions
- Peripheral Artery Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- Trial name
- NCT01790243
- Testing
- Lutonix Drug Coated Balloon, Standard PTA Balloon
- Where
- 8 sites in United States
- Volunteers
- 1,189 people
- Sponsor
- C. R. Bard
PAD
Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter)
This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic…
- Trial name
- DCB (NCT02907203)
- Testing
- Drug Coated Balloon
- Where
- Germany
- Volunteers
- 52 people
- Sponsor
- W.L.Gore & Associates
Benign Prostatic Hyperplasia
Optilume™ BPH Catheter System in Men With Symptomatic BPH
PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)
- Trial name
- PINNACLE (NCT04131907)
- Testing
- Optilume BPH Catheter System
- Where
- 21 sites in United States, Canada
- Volunteers
- 162 people
- Sponsor
- Urotronic Inc.
Peripheral Arterial Disease, Claudication
ILLUMENATE EU Randomized Clinical Trial
This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the…
- Trial name
- EU RCT (NCT01858363)
- Testing
- CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, Bare Percutaneous Transluminal Angioplasty Balloon Catheter
- Where
- Germany
- Volunteers
- 294 people
- Sponsor
- Spectranetics Corporation
Hemodialysis Access Failure
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
- Trial name
- NCT03734679
- Testing
- SurVeil Drug Coated Balloon
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 12 people
- Sponsor
- SurModics, Inc.
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in…
- Trial name
- AGENT IDE (NCT04647253)
- Testing
- AGENT DCB, PTCA balloon catheter
- Where
- 40 sites in United States
- Volunteers
- 600 people
- Sponsor
- Boston Scientific Corporation
Femoropopliteal Artery Lesions
Ranger™ and Ranger™ SL (OTW) DCB) in China
This clinical study is a prospective, non-randomized, multicenter study to demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB in native femoropopliteal artery lesions.
- Trial name
- NCT02944071
- Testing
- Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
- Where
- 9 sites in China
- Volunteers
- 123 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
TurboPower + DCB Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions
A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).
- Trial name
- NCT03306199
- Testing
- Laser Atherectomy
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
Femoral Artery Stenosis, Popliteal Artery Stenosis
Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- CONFIRM (NCT02813577)
- Testing
- Lutonix® 035 Drug Coated Balloon PTA Catheter
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Artery Disease, Peripheral, Femoropopliteal Artery Occlusion
- Trial name
- TRANSCEND (NCT03241459)
- Testing
- Surmodics SurVeil DCB, Medtronic IN.PACT Admiral DCB
- Where
- 63 sites in United States, Australia and 7 more
- Volunteers
- 446 people
- Sponsor
- SurModics, Inc.
Atherosclerosis, Vascular Disease
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.
- Conditions
- Atherosclerosis, Vascular Disease, Arteriosclerosis
- Trial name
- LEVANT I (NCT00930813)
- Testing
- Lutonix Catheter, Standard uncoated Balloon Angioplasty Catheter
- Where
- 10 sites in Belgium, Germany
- Volunteers
- 101 people
- Sponsor
- C. R. Bard
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
PAD, Vascular Calcification
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of…
- Trial name
- OPTIMIZE BTK (NCT02561299)
- Testing
- Peripheral Orbital Atherectomy System, 014 Drug Coated Balloon
- Where
- 7 sites in Austria, Germany
- Volunteers
- 66 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
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.
- Trial name
- NCT01870401
- Testing
- Lutonix DCB, Uncoated PTA Catheter
- Where
- 51 sites in United States, Austria and 6 more
- Volunteers
- 442 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease, Peripheral Vascular Diseases
Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases
- Trial name
- SAFE-DCB (NCT02424383)
- Testing
- PTA (Lutonix® 035 DCB Catheter)
- Where
- 73 sites in United States
- Volunteers
- 1,005 people
- Sponsor
- C. R. Bard
Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.
- Trial name
- EVEREST-I (NCT03423979)
- Testing
- Optilume™ BPH Prostatic DCB Dilation Catheter, Paclitaxel
- Where
- 5 sites in Dominican Republic, Panama
- Volunteers
- 80 people
- Sponsor
- Urotronic Inc.
Coronary Artery Disease
Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
- Trial name
- NCT04058990
- Testing
- Device: Paclitaxel-Coated PTCA Balloon Catheter, SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
- Where
- 14 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
In-Stent Restenosis
PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis
The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter.
- Trial name
- PERVIDEO I (NCT00916279)
- Testing
- Lutonix Paclitaxel-Coated Balloon
- Where
- 8 sites in Belgium, Germany and 1 more
- Volunteers
- 41 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease (PAD)
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug…
- Trial name
- INPACT SFA I (NCT01175850)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- Germany
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular