Clinical trials: Drug-coated Balloon
Coronary Artery Disease, Percutaneous Coronary Intervention
Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies
The goal of this clinical trial is to find out whether a treatment strategy based on a drug-coated balloon (DCB) achieves coronary artery function at 6 months that is not worse than a strategy using only drug-eluting stents (DES)…
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Drug Coated Balloon, Drug Eluting Stents (DES)
- Trial name
- FLOW-DCB (NCT07852689)
- Testing
- Drug-coated balloon-based intervention, Drug-eluting stent-based intervention
- Where
- 4 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Korea University Guro Hospital
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
Peripheral Arterial Disease
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients…
- Trial name
- NCT05868564
- Testing
- Atherectomy+Drug-coated balloon, Drug-coated balloon
- Where
- China
- Volunteers
- 100 people
- Sponsor
- RenJi Hospital
Symptomatic Intracranial Atherosclerotic Stenosis
Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis
To evaluate the safety and efficacy of the Medeliver® Intracranial Drug-Coated Balloon Catheter (developed by Beijing Jiu Shi Shen Kang Medical Technology Co., Ltd.) in the endovascular treatment of symptomatic intracranial…
- Trial name
- NCT07542938
- Testing
- Intracranial Drug-Coated Balloon Catheter (Medeliver®), Intracranial Balloon Dilatation Catheter (Diveroad®)
- Where
- 15 sites in China
- Volunteers
- 264 people
- Sponsor
- Xuanwu Hospital, Beijing
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Arterial Occlusive Diseases
- Trial name
- LEGDEB2 (NCT04175197)
- Testing
- Drug Coated Balloon
- Where
- 7 sites in Italy, Mexico
- Volunteers
- 512 people
- Sponsor
- Federico II University
Critical Limb Ischemia
Investigating the Safety and Efficacy of the Treatment With Luminor DCB and Angiolite DES of iVascular in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia
This study aims to evaluate the 12 month outcome of the mono- or combination therapy with iVascular Luminor DCB and Angiolite DES for treatment of TASC C and TASC D long tibial occlusive disease, presenting with critical limb…
- Trial name
- MERLION (NCT04073121)
- Testing
- Luminor DCB and Angiolite DES
- Where
- 2 sites in Singapore
- Volunteers
- 50 people
- Sponsor
- Singapore General Hospital
Vascular Graft Anastomotic Stenosis
Drug-coated Balloon Versus Conventional Balloon Angioplasty in Hemodialysis Graft
To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis graft, investigators would like to perform randomized study comparing the results of drug- coated balloon angioplasty with conventional…
- Trial name
- NCT02706444
- Testing
- Conventional Balloon angioplasty, Drug-coated Balloon angioplasty
- Volunteers
- 190 people
- Sponsor
- Konkuk University Medical Center
Symptomatic Intracranial Atherosclerotic Stenosis
Drug-Coated Balloon vs Aggressive Medical Management for High-Risk Symptomatic Intracranial Atherosclerotic Stenosis
DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty…
- Trial name
- DRBEYOND2 (NCT07830277)
- Testing
- Drug-Coated Balloon Angioplasty, Aggressive Medical Management
- Where
- 2 sites in China
- Volunteers
- 570 people
- Sponsor
- Beijing Tiantan Hospital
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.
Stable Angina Pectoris, Unstable Angina Pectoris
PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)
This study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.
- Trial name
- NCT03155971
- Testing
- Paclitaxel-Coated Balloon
- Where
- China
- Volunteers
- 60 people
- Sponsor
- The People's Hospital of Liaoning Province
Coronary Artery Disease
DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)
Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm
- Trial name
- NCT06448637
- Testing
- Drug Coated Balloon (DCB), Drug Eluting Stent (DES)
- Where
- 9 sites in Spain
- Volunteers
- 94 people
- Sponsor
- Fundación EPIC
Coronary Artery Disease
Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment
A Pilot Observational Study to evaluate safety and efficacy of the hybrid approach DES/DCB in treating de-novo diffuse lesions
- Trial name
- HYPER (NCT03939468)
- Testing
- DES+DCB
- Where
- 6 sites in Italy
- Volunteers
- 106 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Cardiovascular Diseases
Bioabsorbable Scaffold vs Drug-coated Balloon for Coronary de Novo Lesions in STEMI: Prospective Observational Trial
a prospective, single center, observational clinical trail. Aim to to compare the efficacy and safety of the Bioabsorbable scaffold (BRS) Neovas BRS and Drug-coating balloon (DCB) in the treatment of STEMI patients with coronary…
- Trial name
- NeovasvsDCB (NCT04565561)
- Testing
- Neovas BRS or DCB
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shenzhen People's Hospital
Stenosis, Occlusion
Local Paclitaxel or Balloon Angioplasty Below the Knee
Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries
- Conditions
- Stenosis, Occlusion, Restenosis
- Trial name
- SAMBA (NCT03149913)
- Testing
- SequentPlease OTW paclitaxel coated balloon catheter, conventional uncoated balloon for BTK endovascular therapy
- Where
- 7 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Prof. Dr. med. Gunnar Tepe
Coronary Artery Disease
Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon
Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk.
- Trial name
- ULTIMATE-III (NCT04255043)
- Testing
- IVUS guidance, Angiography guidance
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Coronary Artery Disease
Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease.
- Trial name
- NCT05750771
- Testing
- DES, DCB
- Where
- China
- Volunteers
- 218 people
- Sponsor
- Henan Institute of Cardiovascular Epidemiology
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.
Complex Left Main Bifurcation Stenosis, Left Main Coronary Artery Stenosis
COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.
Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial. Participants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).
- Conditions
- Complex Left Main Bifurcation Stenosis, Left Main Coronary Artery Stenosis, Coronary Bifurcation Stenosis
- Trial name
- COMPETE-LM (NCT07408674)
- Testing
- Angiolite Sirolimus-Eluting Stenting, Essential Pro Paclitaxel Drug-Eluting Balloon
- Volunteers
- 186 people
- Sponsor
- Rede Optimus Hospitalar SA