Clinical trials: Drug Coated Balloon
Peripheral Artery Disease
ACOART BTK RENEW：A Post Market Clinical Study
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee…
- Trial name
- NCT04885985
- Testing
- DEB catheter
- Where
- China
- Volunteers
- 107 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Artery Disease
Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity
The registry will enroll patients with claudication or critical limb ischemia and angiographically significant lesion(s) in arteries of the lower extremity.
- Trial name
- LEG (NCT02043951)
- Testing
- Lutonix Drug Coated Balloon Catheter
- Where
- 8 sites in Canada, Malaysia and 1 more
- Volunteers
- 59 people
- Sponsor
- C. R. Bard
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.
Coronary In Sentrestenosis
The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients
The purpose of this study is to evaluate the efficacy and safety of paclitaxel -eluting PTCA- balloon (SeQuent® Please) in real world Chinese Coronary In Sentrestenosis patients
- Trial name
- NCT03624205
- Testing
- paclitaxel-releasing coronary balloon (SeQuent® Please)
- Volunteers
- 520 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
Intracranial Atherosclerosis, Stroke
AcoArt sICAS: DCB in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial stenosis.
- Trial name
- NCT04631055
- Testing
- drug coated balloon, stent system
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- Acotec Scientific Co., Ltd
Popliteal Artery Disease, Superficial Femoral Artery Disease
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries.
- Trial name
- MAGICAL SFA (NCT07359807)
- Testing
- Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter, Paclitaxel drug-coated balloon angioplasty
- Volunteers
- 478 people
- Sponsor
- Concept Medical Inc.
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 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
Coronary Artery Disease
SELUTION 4 De Novo Small Vessel IDE Trial
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as…
- Trial name
- NCT05946629
- Testing
- PCI with SELUTION SLR DCB, PCI with FDA approved "-limus" DES
- Where
- 70 sites in United States, Belgium and 1 more
- Volunteers
- 960 people
- Sponsor
- M.A. Med Alliance S.A.
In-stent Coronary Artery Restenosis, Coronary Artery Restenosis
Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
- Conditions
- In-stent Coronary Artery Restenosis, Coronary Artery Restenosis, In-stent Restenosis
- Trial name
- RESPECT-ISR (NCT05093244)
- Testing
- SeQuent Please ReX, Plain old balloon angioplasty (POBA)
- Sponsor
- B. Braun Medical Inc.
Coronary Arteriosclerosis
Support C Post-Market Registry
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use.
- Trial name
- NCT06678490
- Where
- 12 sites in Czechia, Germany and 2 more
- Volunteers
- 282 people
- Sponsor
- OrbusNeich
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.
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.
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
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
Coronary Artery Disease, Drug-coated Balloon
Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions
To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75~4.0mm).
- Trial name
- NCT05101005
- Testing
- Drug-Coated Balloon, Sirolimus-Eluting Stent
- Volunteers
- 400 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Stenosis, Occlusion
Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions
Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.
- Conditions
- Stenosis, Occlusion, Restenosis
- Trial name
- SPORTS (NCT03332264)
- Testing
- SeQuent Please OTW, Eluvia Vascular Stent System, Nitinol stent
- Where
- 10 sites in Austria, Germany
- Volunteers
- 224 people
- Sponsor
- InnoRa GmbH
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.
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
Drug Coated Balloon, Bioresorbable Scaffold
Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon [DCB] strategy with bail-out BioResorbable Scaffold [BRS] versus BRS…
- Conditions
- Drug Coated Balloon, Bioresorbable Scaffold, Percutaneous Coronary Intervention (PCI), Acute Coronary Syndrome (ACS)
- Trial name
- LNB (NCT07038408)
- Testing
- Angioplasty with DCB (bail-out BRS), Angioplasty with BRS
- Where
- Estonia
- Volunteers
- 2,256 people
- Sponsor
- Ceric Sàrl