Clinical trials: Drug Coated Balloon
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
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
Angiospastic; Disorder
Safety Assessment of Angioplasty Procedures
Ischemic heart disease, or coronary heart disease, covers a set of pathologies due to insufficient oxygen supply to the myocardium due to the development of atherosclerosis in one or more coronary arteries.
- Trial name
- SCRAP (NCT03893396)
- Testing
- Coronary angioplasty
- Where
- France
- Volunteers
- 983 people
- Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
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
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
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.
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
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
Stricture Urethra
ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
- Trial name
- ROBUST (NCT03014726)
- Testing
- Urotronic Drug Coated Balloon (DCB)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Urotronic Inc.