Clinical trials: Drug-Coated Balloon
Coronary Arteriosclerosis
Support C Post-Market Registry
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting Support C PTCA balloon catheter when used according to the Instructions for Use.
- Trial name
- NCT06678490
- Where
- 12 sites in Czechia, Germany and 2 more
- Volunteers
- 282 people
- Sponsor
- OrbusNeich
Stable Angina, Ischemic Heart Disease
Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID
Bifurcation lesions (BL) on coronary arteries account for 15-20 % of all performed percutaneous coronary interventions (PCI). Preferred approach for treatment of most bifurcation lesions is the stepwise provisional stent strategy…
- Conditions
- Stable Angina, Ischemic Heart Disease, Coronary Artery Disease, Unstable Angina
- Trial name
- PRO-DAVID (NCT04403048)
- Testing
- Provisional DCB approach PCI procedure, Standard provisional approach PCI procedure
- Volunteers
- 800 people
- Sponsor
- Clinical Hospital Center Rijeka
Ischemia; Heart, Stents
Immediate and Short Term Outcomes for Using Drug Coated Balloons in Treating Coronary Bifurcation Lesions
● the investigators aims to study the impact of using drug coated balloon in coronary artery bifurcation lesions on the procedural success rate \& short-term MACE.
- Trial name
- DCB (NCT05872074)
- Testing
- Coronary angiography plus percutenous coronary intervention
- Where
- Egypt
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
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
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
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 Heart Disease, Angioplasty, Balloon
Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients
Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI).
- Trial name
- NCT05937230
- Testing
- Drug-coated balloon, Drug-eluting stents
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Xijing Hospital
Femoropopliteal Artery Occlusion, Atherosclerosis Obliterans
Lesion Preparation in Femoropopliteal Artery Occlusion Disease
Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life.
- Conditions
- Femoropopliteal Artery Occlusion, Atherosclerosis Obliterans, Lesion; Vascular, In-stent Restenosis
- Trial name
- CIVILIAN (NCT05473884)
- Testing
- lesion preparation devices, conventional balloon
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Shanghai Pudong Hospital
ST Elevation Myocardial Infarction (STEMI), Acute Coronary Syndromes (ACS)
A Single-Center, Retrospective, Propensity-Score-Matched Cohort Study Comparing Drug-Coated Balloon Versus Drug-Eluting Stent for Reducing Immediate Post-Procedural Slow-Flow/No-Reflow in Acute ST-Elevation Myocardial Infarction Patients With High Thrombus Burden
This is a single-center, retrospective, propensity-score-matched observational study. It aims to compare the rate of immediate slow-flow or no-reflow after percutaneous coronary intervention (PCI) between drug-coated balloon…
- Trial name
- STEMI-DCB (NCT07806370)
- Testing
- Drug-Coated Balloon (DCB), Drug-Eluting Stent (DES)
- Where
- China
- Volunteers
- 668 people
- Sponsor
- Xijing Hospital
Acute Coronary Syndromes (ACS)
Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment
This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.
- Trial name
- NCT07514988
- Testing
- Sirolimus-coated DCB, Paclitaxel-coated DCB
- Where
- China
- Volunteers
- 60 people
- Sponsor
- China National Center for Cardiovascular Diseases
Chronic Total Occlusion
Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty
Observational retrospective registry to compare effectiveness of paclitaxel-coated vs. non coated balloon angioplasty proximal to a Chronic Total Occlussion (CTO) after failed revascularization.
- Trial name
- IMPROVED-RECTO (NCT05158686)
- Testing
- Paclitaxel-coated Balloon dilation angioplasty, Non-coated Balloon dilation angioplasty
- Where
- Spain
- Volunteers
- 44 people
- Sponsor
- Ignacio J. Amat Santos
Peripheral Artery Disease
Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries
To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long (>10cm) femoropopliteal chronic total occlusion.
- Trial name
- SFPA (NCT03791970)
- Testing
- Orchid 035 DCB Catheter, POBA Catheter
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Coronary Artery Disease
A Study of Drug Coated Balloon For Treating the Side Branch in Complex Bifurcation Lesions
Hypothesis: In patients undergoing coronary stenting for the true bifurcation lesions, main branch stenting followed by side branch dilatation with drug coated balloon is superior to the provisional-stenting strategy in terms of…
- Trial name
- STENT-FREE (NCT05222061)
- Testing
- Drug coated balloon for the side brunch, Conventional balloon for the side brunch
- Where
- Russia
- Volunteers
- 80 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Coronary Artery Disease
DCB Treatment in CTO Guided by IVUS
The percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) coronary artery disease is difficult, the success rate is low, and the incidence of re-occlusion and restenosis is high.
- Trial name
- NCT06050096
- Testing
- PCI
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Xuzhou Central Hospital
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
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
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropopliteal Arterial Disease
The goal of this clinical trial is to learn if using a scoring balloon to prepare the femoropopliteal (FP) segment before drug-coated balloon treatment works better than using a regular balloon (called plain old balloon…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb Ischemia (CLI), Peripheral Arterial Disease
- Trial name
- DASBAD (NCT07136883)
- Testing
- POBA, Scoring Balloon
- Where
- Spain
- Volunteers
- 83 people
- Sponsor
- Marc Sirvent
Cerebral Atherosclerotic Stenosis
Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis
The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis
- Trial name
- NCT06683118
- Testing
- Rapamycin neurovascular Balloon Catheter, Conventional Balloon
- Where
- 2 sites in China
- Volunteers
- 212 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
Hemodialysis Access Failure (Disorder), Stent-Graft Restenosis
DCB for Dialysis Access Stent Graft Restenosis
Recurrent stenosis in hemodialysis access graft (AVG) is difficult to treat. For recurrent stenosis in the anastomotic junction can be treated by stent graft to improve long-term patency.
- Conditions
- Hemodialysis Access Failure (Disorder), Stent-Graft Restenosis, Arteriovenous Graft, Drug-coated Balloon
- Trial name
- NCT03360279
- Testing
- Regular balloon, DCB (paclitaxel-coated balloon)
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
Urethral Stricture
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.
- Trial name
- ROBUST-II (NCT03270384)
- Testing
- Urotronic Drug Coated Balloon (DCB)
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- Urotronic Inc.