Clinical trials: Drug-Coated Balloon
Coronary Disease, Heart Diseases
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia
- Trial name
- PIV-EPIC (NCT06535568)
- Testing
- Drug-coated balloon, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT)
- Where
- Italy
- Volunteers
- 576 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
Drug-coated Balloon Catheter
Follow-up Study in French Practice to Evaluate Improvements in Walking and Pain Relief in Patients Treated With Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon
This study is part of the subordination for the renewal of the registration of the LUTONIXR035 or RANGERTM drug coated balloon catheter by the CNEDiMTS following the transmission of the results of a French study on quality of…
- Trial name
- EQUATEUR (NCT04798352)
- Testing
- 6-minute walk test, WIQ functional questionnaire, quality of life questionnaires (EQ5D5L and SF-36)
- Where
- France
- Volunteers
- 293 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Coronary Artery Disease
Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk
This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive…
- Trial name
- PREPARE-NSE (NCT03817801)
- Testing
- NSE balloon, NC balloon
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Drug-coated Balloon
Drug-coated Balloon Treatment in Coronary Lesions
This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions
- Trial name
- NCT06265324
- Testing
- Angioplasty
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Sohag University
Coronary Artery Disease
Drug-Coated Balloon Versus Drug-eluting Stent Angioplasty for Treatment of Chronic Total Occlusion - The DCB-CTO Trial
Chronic total occlusion (CTO) remains one of the most challenging lesions in coronary artery disease management. Percutaneous coronary intervention using drug-eluting stents is currently a standard treatment approach; however…
- Trial name
- DCB-CTO (NCT07369765)
- Testing
- Drug-Eluting Stent Group, Drug Coated Balloon Group
- Where
- Turkey (Türkiye)
- Volunteers
- 200 people
- Sponsor
- Biruni University
Peripheral Artery Disease
Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis
The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. Forty-five patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters…
- Trial name
- PACIFIER (NCT01083030)
- Testing
- Percutaneous transluminal angioplasty (PTA), DCB
- Where
- 3 sites in Germany
- Volunteers
- 90 people
- Sponsor
- University Hospital, Saarland
Coronary Heart Disease, Angioplasty, Balloon
The Clinical Efficacy and Safety of Drug-coated Balloon
Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon.
- Trial name
- NCT05133921
- Where
- China
- Volunteers
- 2,487 people
- Sponsor
- Xijing Hospital
Chronic Coronary Syndrome
OPtimization of Antiplatelet Therapy After the intervenTION of de Novo Coronary Artery Lesions With Drug-Coated Balloons
Coronary atherosclerotic disease remains one of the leading causes of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) and drug-eluting stents (DES) implantation has significantly improved…
- Trial name
- OPTION-DCB (NCT07815106)
- Testing
- 1-month DAPT, 6-month DAPT
- Volunteers
- 2,122 people
- Sponsor
- Shanghai Zhongshan Hospital
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 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
Benign Prostatic Hyperplasia
OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.
- Trial name
- APEX (NCT06560476)
- Testing
- Data collection
- Where
- 8 sites in United States
- Volunteers
- 500 people
- Sponsor
- Urotronic Inc.
Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
Drug Coated Balloon vs. Drug-eluting Stent in Patients With Coronary Artery Disease
Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in…
- Trial name
- DCB_DES (NCT07442500)
- Testing
- Drug coated balloon, Drug-eluting stent
- Where
- South Korea
- Volunteers
- 470,000 people
- Sponsor
- Samsung Medical Center
Drug-coated Balloon
Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.
- Trial name
- NCT04619277
- Testing
- drug-coated balloon
- Where
- South Korea
- Volunteers
- 10,000 people
- Sponsor
- Ulsan Medical Center
Coronary Artery Disease
Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions
This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.
- Trial name
- BABILON (NCT01278186)
- Testing
- Balloon angioplasty, Stent implantation
- Where
- 9 sites in Spain
- Volunteers
- 190 people
- Sponsor
- B.Braun Surgical SA
Coronary Artery Disease
Drug-coated Balloon Treatment
Evaluation of the efficacy and clinical outcomes of drug-eluting balloon therapy in ticyaici coronary artery disease.
- Trial name
- DCB-ONE TR (NCT07794839)
- Testing
- drug coated balloon, drug eluting stent
- Where
- Turkey (Türkiye)
- Volunteers
- 1,000 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital