Clinical trials: Drug Coated Balloon
Femoral Artery Stenosis, Popliteal Artery Stenosis
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- MDT-2113 SFA (NCT01947478)
- Testing
- MDT-2113 Drug-Eluting Balloon, Standard angioplasty balloon
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic Endovascular
Bifurcation Lesions, Drug Eluting Balloon
Bingo Drug-eluting Balloon in Bifurcation
The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.
- Trial name
- NCT02325817
- Testing
- Drug-eluting balloon, Uncoated ballloon
- Where
- China
- Volunteers
- 222 people
- Sponsor
- Yinyi(Liaoning) Biotech Co., Ltd.
Peripheral Artery Disease
AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal…
- Trial name
- NCT03267056
- Testing
- drug eluting balloon catheter (trade name: Orchid)
- Where
- 10 sites in China
- Volunteers
- 120 people
- Sponsor
- Acotec Scientific Co., Ltd
Chinese Patients Treated With Agent DCB
An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients
To compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients.
- Trial name
- NCT04085445
- Testing
- AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter
- Where
- 9 sites in Hong Kong, Singapore and 1 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease, Myocardial Ischaemia
SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)
The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC)…
- Trial name
- SCORE (NCT04470934)
- Testing
- SeQuent® SCB drug-coated balloon catheter
- Where
- Germany
- Volunteers
- 1,302 people
- Sponsor
- B. Braun Melsungen AG
Coronary Artery Disease
The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.
The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the bare metal Bx…
- Trial name
- RAVEL (NCT00233805)
- Testing
- Sirolimus coated Bx Velocity™, Bare metal Bx Velocity™
- Where
- France
- Volunteers
- 220 people
- Sponsor
- Cordis US Corp.
Central Airway Obstruction
Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis
The goal of this Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1) is to evaluate clinical safety and potential efficacy of the Airiver Pulmonary DCB in the…
- Trial name
- NCT05895305
- Testing
- Paclitaxel-Coated Pulmonary Balloon Catheter
- Where
- Georgia
- Volunteers
- 45 people
- Sponsor
- Airiver Medical, Inc.
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 Occlusive Disease
"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes
The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow…
- Trial name
- LOCOMOTIVE (NCT02531230)
- Testing
- VascuFlex Multi-LOC®
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- B. Braun Melsungen AG
Peripheral Artery Disease
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or…
- Trial name
- PK (NCT01912937)
- Testing
- Angioplasty treatment with the CVI Drug-coated Balloon (DCB)
- Where
- 2 sites in New Zealand
- Volunteers
- 25 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
Coronary Artery Disease
Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary Bifurcated Lesions
The purpose of this study is to evaluate the efficacy and safety of Microport sirolimus drug coated balloon catheter for the treatment of coronary bifurcation lesions.
- Trial name
- PROMISE-BIF (NCT04918615)
- Testing
- PCI
- Where
- China
- Volunteers
- 236 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions.
- Trial name
- NCT07326735
- Testing
- Mamba Sirolimus-Eluting PTCA Balloon, Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon
- Where
- 2 sites in Burma, Malaysia
- Volunteers
- 360 people
- Sponsor
- Frisch Medical Device Private Limited
Peripheral Artery Disease
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.
- Trial name
- NCT05415995
- Testing
- Drug eluting Balloon
- Where
- 20 sites in China
- Volunteers
- 202 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Peripheral Arterial Occlusive Disease
"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes (LOCOMOTIVE Extended)
The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow…
- Trial name
- NCT02900274
- Testing
- VascuFlex Multi-LOC®
- Where
- Germany
- Volunteers
- 353 people
- Sponsor
- B. Braun Melsungen AG
Coronary Artery Disease, Myocardial Ischemia
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery…
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Coronary Stenosis
- Trial name
- REVERSE (NCT05846893)
- Testing
- SeQuent® Please NEO drug-coated balloon catheter, Current-generation drug-eluting stent
- Where
- 21 sites in Malaysia, Singapore and 2 more
- Volunteers
- 1,436 people
- Sponsor
- B. Braun Medical Industries Sdn. Bhd.
Peripheral Artery Disease (PAD)
Α Pre CE-Marking Study Using the Rontis Drug Coated Balloon for Treatment of Lesions in Femoropopliteal Arteries
The Rontis Drug Coated - Peripheral Balloon Catheter is intended for PTA procedure on atherosclerotically stenotic or obstructed vessels and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis…
- Trial name
- NCT04821388
- Testing
- Rontis DCB
- Where
- 5 sites in Greece
- Volunteers
- 30 people
- Sponsor
- Rontis Hellas SA
Coronary Artery Disease
Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions
Bingo drug-eluting balloon versus a drug-eluting stent for coronary bifurcation lesions: a prospective, multi-center, randomized, non-inferiority trial
- Trial name
- NCT06441539
- Testing
- Bingo® Paclitaxel coated balloon, Xience® Alpine Everolimus Eluting Coronary Stent System
- Volunteers
- 218 people
- Sponsor
- Yinyi(Liaoning) Biotech Co., Ltd.
Urethral Stricture, Urethral Stricture, Anterior
Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study
The ROBUST IV study is designed to collect and better understand "real-world" outcomes for men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment of urethral stricture.
- Conditions
- Urethral Stricture, Urethral Stricture, Anterior, Lower Urinary Tract Symptoms, Anterior Urethral Stricture
- Trial name
- ROBUST IV (NCT03851952)
- Testing
- Optilume Drug Coated Balloon
- Sponsor
- Urotronic Inc.
Peripheral Arterial Disease
CVI Drug Coated Balloon First In Human Trial
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or…
- Trial name
- NCT02110524
- Testing
- Percutaneous Transluminal Angioplasty
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Spectranetics Corporation