Clinical trials: Drug-Coated Balloon
Peripheral Arterial Disease
IN.PACT Global Clinical Study
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world"…
- Trial name
- NCT01609296
- Testing
- IN.PACT Admiral™ Drug Eluting Balloon
- Where
- 65 sites in Argentina, Australia and 25 more
- Volunteers
- 1,535 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease
Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with…
- Trial name
- HEROES-DCB (NCT02812966)
- Testing
- Lutonix, IN.PACT
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Wake Forest University Health Sciences
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
Urethral Stricture
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).
- Trial name
- ROBUST-III (NCT03499964)
- Testing
- Optilume Drug Coated Balloon (DCB), Control Treatment
- Where
- 22 sites in United States, Canada
- Volunteers
- 127 people
- Sponsor
- Urotronic Inc.
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 Artery Disease, Vascular Disease
Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging
This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the…
- Conditions
- Peripheral Artery Disease, Vascular Disease, Critical Limb Ischemia
- Trial name
- INVADER_MRI (NCT02807779)
- Testing
- Dexamethasone infusion, Drug coated balloon, Plain balloon angioplasty
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of California, San Francisco
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
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
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