Clinical trials: Drug Coated Balloon
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
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
Popliteal Stenosis, Popliteal Artery Occlusion
DCB Compared Stenting in Popliteal Lesions
This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.
- Conditions
- Popliteal Stenosis, Popliteal Artery Occlusion, Diabetes
- Trial name
- NCT03739580
- Testing
- DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.), Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Xuanwu Hospital, Beijing
Coronary Artery Disease
Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary Bifurcated Lesions
The purpose of this study is to evaluate the efficacy and safety of Microport sirolimus drug coated balloon catheter for the treatment of coronary bifurcation lesions.
- Trial name
- PROMISE-BIF (NCT04918615)
- Testing
- PCI
- Where
- China
- Volunteers
- 236 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Artery Disease
Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo Lesions
Trial name Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo Lesions Objectives To compare the safety and efficacy of Drug-Coated Balloons (DCB)…
- Trial name
- LARGE (NCT07548281)
- Testing
- DCB in large de novo coronary lesions guided by IVUS and AngioFFR, DES in large de novo coronary lesions guided by IVUS and AngioFFR
- Volunteers
- 2,492 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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
Peripheral Vascular Diseases
Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons
DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe [8], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease…
- Trial name
- Remove (NCT04986098)
- Testing
- TurboHawk, Paclitaxel
- Where
- China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Soochow University
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
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions.
- Trial name
- NCT07326735
- Testing
- Mamba Sirolimus-Eluting PTCA Balloon, Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon
- Where
- 2 sites in Burma, Malaysia
- Volunteers
- 360 people
- Sponsor
- Frisch Medical Device Private Limited
In-Stent Restenosis
Treatment of Drug-eluting Stent (DES) In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
The aim of the study is to assess the efficacy of the Paclitaxel-eluting PTCA - balloon catheter SeQuent® Please to treat in-stent restenoses (ISR) of various drug eluting stents in native coronary arteries with reference…
- Trial name
- NCT00998439
- Testing
- SeQuent® Please, SeQuent® II
- Where
- 8 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Klinikum Coburg
ST Elevation Myocardial Infarction (STEMI)
Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction…
- Trial name
- BOOST-AMI (NCT06746233)
- Testing
- Drug (paclitaxel) coated balloon (DCB), Second-generation Drug Eluting Stent (DES)
- Where
- 5 sites in Bosnia and Herzegovina, Serbia
- Volunteers
- 598 people
- Sponsor
- Institute of Cardiovascular Diseases, Vojvodina
Unprotected Left Main Coronary Artery Disease
Comparison of HYBRID Versus Two-Stent Strategies in Unprotected True Left MAIN Bifurcation
The number of deaths from heart disease is rising globally, particularly in developing countries. This condition involves the narrowing of arteries that supply blood to the heart.
- Trial name
- HYBRID MAIN (NCT07159737)
- Testing
- Two-stent strategy, Hybrid Strategy
- Volunteers
- 800 people
- Sponsor
- Hospital Sultanah Bahiyah
Coronary Artery Disease, Acute Myocardial Infarction
Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction
Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous coronary intervention (PPCI).
- Trial name
- REVELATION (NCT02219802)
- Testing
- Treatment according arm
- Where
- Netherlands
- Volunteers
- 120 people
- Sponsor
- Onze Lieve Vrouwe Gasthuis
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
Neointimal Hyperplasia, Dialysis Access Malfunction
A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
Arteriovenous Fistula (AVF) is a surgically created circuit used for hemodialysis in patient with End Stage Renal Disease (ESRD).
- Trial name
- PREDATOR (NCT05360394)
- Testing
- Paclitaxel Coated Balloon, Paclitaxel Coated Balloon and Stent Graft
- Where
- 2 sites in Australia, Singapore
- Volunteers
- 80 people
- Sponsor
- Singapore General Hospital
Peripheral Artery Disease
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases
This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.
- Trial name
- NCT05415995
- Testing
- Drug eluting Balloon
- Where
- 20 sites in China
- Volunteers
- 202 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Coronary Stent Restenosis
Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis
The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR).
- Trial name
- OPEN-ISR (NCT04862052)
- Testing
- Intravascular management of prior implanted coronary drug eluting stent restenosis
- Where
- 2 sites in Hungary
- Volunteers
- 108 people
- Sponsor
- Semmelweis University Heart and Vascular Center
Critical Lower Limb Ischemia, Peripheral Artery Disease
Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore
Extensive arterial occlusion significantly reduces arterial perfusion, and may eventually lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic pain, slow healing wounds at lower extremity…
- Trial name
- PRISTINE (NCT04534257)
- Testing
- SELUTION Sirolimus DCB
- Where
- Singapore
- Volunteers
- 75 people
- Sponsor
- Singapore General Hospital
Drug-coated Balloon
DCB in de Novo Coronary Lesion
Intro-stent restenosis, bifurcation lesions and small vascular lesion with diameter <2.75mm is the indication of drug coated balloon.
- Trial name
- NCT03691675
- Testing
- Drug coated balloon
- Volunteers
- 45 people
- Sponsor
- Second Hospital of Jilin University
Coronary Artery Disease
Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease
The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary…
- Trial name
- NCT00192881
- Testing
- Bx Sonic & Cypher stent from Cordis
- Where
- Denmark
- Sponsor
- Copenhagen University Hospital, Rigshospitalet