Clinical trials: Drug-Coated Balloon
Drug Coating Balloon (DCB), Sequent Please
SeQuent Please Neo Multicenter Registry
The registry evaluates the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial…
- Trial name
- NCT04493112
- Where
- Spain
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Germans Trias i Pujol Hospital
Chronic Limb Threatening Ischemia
Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI
Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis.
- Trial name
- LASER-S (NCT07858539)
- Testing
- Laser atherectomy followed by Sirolimus-coated balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
- Where
- Greece
- Volunteers
- 55 people
- Sponsor
- Attikon Hospital
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
Coronary Artery Disease (CAD)
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
This study will compare the effectiveness of the TRADENT™ coronary scoring balloon with a conventional non-scoring balloon for lesion preparation in patients undergoing a drug-coated balloon (DCB)-first percutaneous coronary…
- Trial name
- TRAD-PREP (NCT07899021)
- Testing
- TRADENT Scoring Balloon, Conventional Non-Scoring Coronary Balloon
- Volunteers
- 580 people
- Sponsor
- Ulsan University Hospital
Peripheral Arterial Disease
CVI Drug Coated Balloon First In Human Trial
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or…
- Trial name
- NCT02110524
- Testing
- Percutaneous Transluminal Angioplasty
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Spectranetics Corporation
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, Atherectomy in Diseased Lower Extremity Arteries
Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions
Peripheral artery disease can reduce blood flow to the legs. In some patients, the superficial femoral artery, a major artery in the thigh, is completely blocked over a long segment.
- Trial name
- NCT07803718
- Testing
- Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Sakarya University
De Novo Stenosis, Coronary Artery Disease
Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions
The introduction of Bare-metal stents (BMS) since 1986 has alleviated the limitations of plain old balloon angioplasty (POBA) related elastic recoil and flow-limiting dissections.
- Trial name
- NCT04561739
- Testing
- Paclitaxel coated balloon, Sirolimus eluting stents
- Where
- China
- Volunteers
- 2,272 people
- Sponsor
- Xijing Hospital
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
Peripheral Arterial Disease
A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon.
The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon…
- Trial name
- BIOPACT-RCT (NCT03884257)
- Testing
- Passeo-18 Lux treatment group, IN.PACT Admiral treatment group
- Where
- 14 sites in Austria, Belgium and 2 more
- Volunteers
- 302 people
- Sponsor
- KANDO Research
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.
Takayasu Arteritis
Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis
Takayasu arteritis associated renal artery stenosis (TARAS) is the biggest cause of hypertension in young people <40 years old. Hypertension caused by renal artery stenosis is usually hard to control in spite of two or more…
- Trial name
- NCT04137614
- Testing
- Drug coated balloon (DCB), Digital substraction angiography (DSA)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Zhongshan Hospital
Coronary Artery Disease
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to…
- Trial name
- PARIS (NCT06321757)
- Testing
- Percutaneous Coronary Intervention with DCB and DAPT
- Where
- 19 sites in Italy, Portugal and 1 more
- Volunteers
- 501 people
- Sponsor
- Fundación EPIC
Femoral Artery Stenosis, Popliteal Artery Stenosis
Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- CONFIRM (NCT02813577)
- Testing
- Lutonix® 035 Drug Coated Balloon PTA Catheter
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- C. R. Bard
Restenosis, Stable Angina Pectoris
Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4
The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis within "limus"-eluting stents (LES)
- Conditions
- Restenosis, Stable Angina Pectoris, Acute Coronary Syndrome
- Trial name
- ISAR-DESIRE 4 (NCT01632371)
- Testing
- Paclitaxel Eluting Balloon + Scoring Balloon, Paclitaxel Eluting Balloon
- Where
- 2 sites in Germany
- Volunteers
- 252 people
- Sponsor
- Deutsches Herzzentrum Muenchen
In-Stent Coronary Artery Restenosis, Coronary Artery Disease
The PICCOLETO XI A-PREP Study
To compare the angiographic and clinical outcomes of aggressive versus standard balloon preparation during drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR).
- Trial name
- PICCOLETO-XI (NCT07391033)
- Volunteers
- 500 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
Coronary Artery Disease
ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)
The primary objective of this protocol is to develop a comprehensive, multicenter international prospective registry to capture long-term clinical outcomes for adult patients undergoing percutaneous coronary intervention (PCI)…
- Trial name
- NCT07559903
- Where
- 19 sites in United States, Germany and 1 more
- Volunteers
- 5,000 people
- Sponsor
- Emory University
Ischaemic Heart Disease
Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience From 2009 to 2015
This is a single center, retrospective, observational cohort study to assess the safety and efficacy of drug coated balloon (DCB) angioplasty in all forms of coronary artery disease.
- Trial name
- DCBNORWICH (NCT03603210)
- Testing
- Drug coated balloon angioplasty
- Where
- United Kingdom
- Volunteers
- 1,000 people
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
Vertebral Artery Origin Stenosis
Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study
There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.
- Trial name
- NCT03311360
- Testing
- drug-coated balloon, bare metal stent
- Where
- 9 sites in China
- Volunteers
- 95 people
- Sponsor
- Chinese Society of Interventional Radiology
Femoral Artery Stenosis, Femoral Artery Occlusion
A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries
To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Stenosis of Popliteal Arteries, Occlusion of Popliteal Arteries
- Trial name
- NCT02720003
- Testing
- LTX DCB
- Where
- 14 sites in China
- Volunteers
- 148 people
- Sponsor
- C. R. Bard