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.
Coronary Disease
Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.
Significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. Independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization…
- Trial name
- RAMSES (NCT01722799)
- Testing
- Drug elluting Balloon (DEB), Drug elluting coronary stent (DES)
- Where
- Spain
- Volunteers
- 97 people
- Sponsor
- Andres Iñiguez Romo, MD, PhD
Arterial Occlusive Disease
Infrapopliteal Drug Eluting Angioplasty Versus Stenting
In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal…
- Trial name
- IDEAS-I (NCT01517997)
- Testing
- Paclitaxel coated balloon angioplasty., Infrapopliteal Primary Drug Eluting Stenting
- Where
- Greece
- Volunteers
- 50 people
- Sponsor
- University of Patras
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
CAD - Coronary Artery Disease
REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients
A post marketing, observational , multi centre, prospective registry to assess safety and performance of the Drug Eluting Balloon in patients undergoing percutaneous coronary intervention.
- Trial name
- REPEAT (NCT06899555)
- Volunteers
- 500 people
- Sponsor
- Craigavon Area Hospital
Antiplatelet Drug, Acute Coronary Syndrome
1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With 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 to the balloon.
- Conditions
- Antiplatelet Drug, Acute Coronary Syndrome, Angioplasty, Balloon
- Trial name
- CAGEFREEII (NCT04971356)
- Testing
- Aspirin 100mg for 1-month (immediately after PCI), Ticagrelor 90mg for 6-month (immediately after PCI), Aspirin 100mg for 6-month (6-month post PCI)
- Where
- China
- Volunteers
- 1,948 people
- Sponsor
- Xijing Hospital
Angioplasty, Balloon
Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis
The aim of this multicenter triple-arm randomized study is to compare two innovative techniques with the gold standard currently used and providing unsatisfactory results for the In-Stent Restenosis (ISR) treatment in…
- Trial name
- INTACT (NCT02599389)
- Testing
- Drug-coated balloons, Excimer Laser
- Where
- 13 sites in France
- Volunteers
- 222 people
- Sponsor
- University Hospital, Bordeaux
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.
Arteriovenous Shunt Thrombosis, Blood Vessel Prosthesis
Sirolimus Drug-coated Balloon Versus Stent Graft
A functioning dialysis vascular access is critical to the delivery of lifesaving hemodialysis. Arteriovenous graft (AVG) is a surgically created vascular access used for hemodialysis in patients with end-stage renal disease.
- Trial name
- SUSTAIN (NCT05938530)
- Testing
- Sirolimus drug-coated balloon, Stent graft
- Where
- Singapore
- Volunteers
- 100 people
- Sponsor
- Singapore General Hospital
Coronary Artery Disease, Drug-eluting Stents
Kor PCI - CAD Patients Treated With PCI: Analysis of the Korean Nationwide Health Insurance Database
Current Status and Prognosis of Coronary artery disease patients treated with coronary intervention - Analysis of the Korean Nationwide Health Insurance Database
- Conditions
- Coronary Artery Disease, Drug-eluting Stents, Drug-coated Balloon
- Trial name
- NCT04778969
- Testing
- drug-eluting stent, drug-coated balloon
- Volunteers
- 200,000 people
- Sponsor
- Seoul National University Hospital
Cardiovascular Diseases
Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment
This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm.
- Trial name
- PICCOLETO II (NCT03899818)
- Testing
- drug-eluting balloon, drug-eluting stent
- Volunteers
- 240 people
- Sponsor
- Fatebenefratelli and Ophthalmic Hospital
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.
Coronary Artery Disease
Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
- Trial name
- LARGER-DCB (NCT06954714)
- Testing
- Drug-eluting stent implantation, Drug-coated balloon angioplasty
- Where
- 8 sites in South Korea
- Volunteers
- 256 people
- Sponsor
- Chonnam National University Hospital
Peripheral Artery Disease
Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease
This study is a prospective, interventional, multicenter 1:1 randomized trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control…
- Trial name
- LIMES (NCT04772300)
- Testing
- Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter, Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)
- Where
- 19 sites in Austria, Germany
- Volunteers
- 230 people
- Sponsor
- Jena University Hospital
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
Angina (Stable), Coronary Occlusion
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Chronic total occlusions (CTO) of the coronary arteries are usually treated with drug-eluting stents (DES) after successful recanalization.
- Conditions
- Angina (Stable), Coronary Occlusion, Coronary Artery Disease, Chronic Total Occlusion
- Trial name
- NoTrace-CTO (NCT07817719)
- Testing
- Paclitaxel-coated balloon (AGENT Paclitaxel-Coated PTCA Balloon Catheter), Serial intravascular ultrasound and protocol-mandated nine-month angiographic reassessment
- Where
- Brazil
- Volunteers
- 38 people
- Sponsor
- University of Sao Paulo General Hospital