Clinical trials: Drug Coated Balloon
Coronary Artery Disease (non-left Main), Coronary Bifurcation Lesion
The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations
Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice.
- Trial name
- EBC DCB (NCT06822322)
- Testing
- Percutaneous Coronary Angioplasty, Stepwise Provisional Stent Strategy, Drug Coated Balloon Strategy
- Volunteers
- 750 people
- Sponsor
- Ceric Sàrl
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
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length…
- Trial name
- AGENT IDE (NCT06492174)
- Testing
- AGENT DCB 40 mm
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Femoral Artery Stenosis, Popliteal Artery Stenosis
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- INPACT SFA II (NCT01566461)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- 2 sites in United States
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular
Atherosclerosis
Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease
A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.
- Trial name
- NCT02710656
- Testing
- Legflow® balloon, Standard PTA
- Where
- 9 sites in Belgium, France and 1 more
- Volunteers
- 130 people
- Sponsor
- Cardionovum GmbH
In-Stent Restenosis, Cardiovascular Diseases
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.
- Conditions
- In-Stent Restenosis, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- MAGICAL ISR (NCT05908331)
- Testing
- Sirolimus Drug Coated Balloon, Plan balloon Angioplasty (POBA)
- Where
- 28 sites in United States
- Volunteers
- 492 people
- Sponsor
- Concept Medical Inc.
Peripheral Arterial Disease, Critical Limb Ischemia
A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB
This is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a…
- Trial name
- DEEPER LIMUS (NCT04162418)
- Testing
- Temporary Spur Stent System
- Where
- Austria
- Volunteers
- 26 people
- Sponsor
- ReFlow Medical, Inc.
Peripheral Arterial Disease, Claudication
Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease
The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon…
- Trial name
- DEFINITIVE AR (NCT01366482)
- Testing
- Cotavance Drug-Eluting Balloon, TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
- Where
- Belgium
- Volunteers
- 121 people
- Sponsor
- Medtronic Endovascular
Coronary Artery Disease, In-Stent Restenosis
Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study
The study is a Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis. It is a First-in-Man Trial.
- Trial name
- REFORM (NCT04079192)
- Testing
- Biolimus A9 Drug Coated Balloon, SeQuent Please Paclitaxel Drug Coated Balloon
- Where
- 15 sites in Germany, Ireland and 3 more
- Volunteers
- 201 people
- Sponsor
- Biosensors Europe SA
Bowel; Stricture
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
- Trial name
- PATENT-B (NCT05561127)
- Testing
- GIE Medical ProTractX3 TTS DCB, Control
- Where
- 33 sites in United States
- Volunteers
- 171 people
- Sponsor
- GIE Medical
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
Patients With de Novo Coronary Artery Lesions
A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions
To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.
- Trial name
- NCT07582250
- Testing
- Biolimus-Coated Coronary Artery Balloon Dilatation Catheter, Xinyue Drug-Coated Stent System
- Volunteers
- 1,548 people
- Sponsor
- JW Medical Systems Ltd
Peripheral Vascular Disease
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial
This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease.
- Trial name
- ENDURE (NCT02129127)
- Testing
- Paclitaxel Coated Chocolate Balloon Angioplasty
- Where
- 2 sites in Germany, New Zealand
- Volunteers
- 67 people
- Sponsor
- TriReme Medical, LLC
Arteriovenous Fistula Stenosis
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous…
- Trial name
- SCDB (NCT06422845)
- Testing
- Dissolve AV Peripheral Scoring Drug-coated Balloon
- Where
- 33 sites in China
- Volunteers
- 328 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Coronary Artery Disease, Coronary Restenosis
Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.
To determine in a randomized controlled trial (RCT) whether percutaneous coronary intervention - in patients with in-stent restenosis in either bare metal stents or drug eluting stents - with the Pantera Lux balloon is…
- Trial name
- BIOLUX-RCT (NCT01651390)
- Testing
- Percutaneous coronary intervention
- Where
- 14 sites in Germany, Latvia
- Volunteers
- 231 people
- Sponsor
- Biotronik AG
Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease
VITUS Post-Market Registry
To collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (PAOD) intended to be or treated by the VITUS peripheral drug-coated dilatation catheter when used according to the…
- Trial name
- NCT06832631
- Testing
- Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 283 people
- Sponsor
- OrbusNeich
Femoropopliteal Occlusive Disease, Peripheral Artery Disease
Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.
Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.
- Trial name
- KANSHAS-1 (NCT02939924)
- Testing
- Kanshas DCB
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 50 people
- Sponsor
- Terumo Europe N.V.
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.
Stenosis of Native Hemodialysis Arteriovenous Fistulas
ACOART AVF 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 Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in…
- Trial name
- NCT06205576
- Testing
- DCB catheter
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Acotec Scientific Co., Ltd
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