Clinical trials: Drug Coated Balloon, open to volunteers
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
Hemodialysis Access Failure
Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
This study was aimed at comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.This is a prospective, multi-center cohort study.
- Trial name
- NCT06493292
- Testing
- Endovascular therapy
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- RenJi Hospital
Coronary Artery Disease
The PICCOLETO IX PHENO Study
To investigate whether pre-procedural OCT-derived de novo coronary lesion phenotype (lipid-rich, fibrotic, calcific; and ACS mechanisms such as plaque rupture/erosion/calcified nodule) is associated with clinical outcomes after…
- Trial name
- PIX-PHENO (NCT07390994)
- Volunteers
- 600 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
Coronary Artery Disease, Diffuse Coronary Artery Disease
Hybrid Percutaneous Coronary Intervention Combining a Bioresorbable Scaffold With Drug-coated Balloons Versus a Conventional Drug-eluting Stent-based Strategy in Patients With Long and Diffuse Coronary Artery Disease
The primary objective of the study is to assess the safety and the efficacy of a hybrid percutaneous coronary intervention (PCI) strategy combining a magnesium-based sirolimus-eluting bioresorbable scaffold (Freesolve, Biotronik…
- Conditions
- Coronary Artery Disease, Diffuse Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
- Trial name
- BIOHYBRID (NCT06710210)
- Testing
- PCI with a bioresorbable scaffold and drug-coated balloon(s), PCI with drug-eluting stent(s)
- Where
- 4 sites in Switzerland
- Volunteers
- 150 people
- Sponsor
- University Hospital, Geneva
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
Femoropopliteal In-Stent Restenosis (ISR)
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal in-stent restenosis (ISR) remains an important cause of recurrent symptoms and repeat revascularization after lower-extremity endovascular treatment.
- Trial name
- NCT07277218
- Testing
- Drug-Coated Balloon-First Strategy, Eluvia Drug-Eluting Stent-First Strategy
- Where
- 10 sites in China
- Volunteers
- 600 people
- Sponsor
- Chunshui He
Coronary Heart Disease
Safety and Efficacy of DCB Therapy for de Novo Lesions Under the Guidance of QFR in CHD Patients (UNIQUE-DCB-I Study )
Since Gruntzig successfully performed percutaneous coronary balloon angioplasty in 1977, percutaneous coronary intervention has developed rapidly.
- Trial name
- NCT04104854
- Testing
- drug coated balloon
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Arteriovenous Fistula, Angioplasty, Balloon
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis
The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are…
- Conditions
- Arteriovenous Fistula, Angioplasty, Balloon, Hemodialysis Access Failure
- Trial name
- Dragon (NCT06527963)
- Testing
- Endovascular therapy
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- RenJi Hospital
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
Coronary Disease, Heart Diseases
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia
- Trial name
- PIV-EPIC (NCT06535568)
- Testing
- Drug-coated balloon, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT)
- Where
- Italy
- Volunteers
- 576 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
Coronary Artery Disease, Drug Eluting Balloon
Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial
The main objective of the SPARX trial is to compare paclitaxel-coated balloons to with contemporary DES in complex and small coronary artery lesions in patients with NSTEACS or CCS; the co-primary objective is to compare two…
- Conditions
- Coronary Artery Disease, Drug Eluting Balloon, Drug Eluting Stent
- Trial name
- SPARX RCT (NCT07397845)
- Testing
- Protégé and Protégé NC, Agent, Drug Eluting Stent
- Where
- Switzerland
- Volunteers
- 1,380 people
- Sponsor
- Translumina GmbH
Coronary Artery Disease (CAD), ST-elevation Myocardial Infarction (STEMI)
Drug-coatEd Balloon Multicentric Registry in Spain and PORTugal
Drug-eluting stents (DES) have been the main treatment option for coronary angioplasty (PCI) for many years. The antiproliferative drug in DES has the effect of preventing in-stent restenosis, which is typically a consequence of…
- Trial name
- DESPORT (NCT07477405)
- Volunteers
- 1,200 people
- Sponsor
- Portuguese Association of Interventional Cardiology
Femoropopliteal Artery Stenoses or Occlusive Lesions
A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.
T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.
- Trial name
- NCT07187128
- Testing
- drug coating balloon angioplasty
- Where
- 2 sites in China
- Volunteers
- 150 people
- Sponsor
- BrosMed Medical Co., Ltd
Coronary Artery Disease (CAD)
1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention
This study will compare the clinical outcomes of a 1-month dual antiplatelet therapy (DAPT) strategy with a standard 6-month DAPT strategy in patients undergoing successful drug-coated balloon-only percutaneous coronary…
- Trial name
- ADAPT-DCB (NCT07879430)
- Testing
- 1-Month DAPT, 6-Month DAPT
- Volunteers
- 1,258 people
- Sponsor
- Ulsan University Hospital
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
Angina (Stable), CAD - Coronary Artery Disease
Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease
The study objectives are: 1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease. 2.
- Conditions
- Angina (Stable), CAD - Coronary Artery Disease, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- ADVANCE-DUO (NCT07368933)
- Testing
- SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter
- Where
- 3 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Advanced NanoTherapies
Coronary Arterial Disease (CAD)
Drug-Coated Coronary Balloons in Different Clinical Scenarios
Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions.
- Trial name
- DCB-DCS (NCT06915597)
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 1,500 people
- Sponsor
- Kutahya Health Sciences University
Arteriovenous Fistula, Arteriovenous Fistula Stenosis
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty
- Conditions
- Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Dialysis Access Malfunction
- Trial name
- RANGER (NCT06553443)
- Testing
- Angioplasty of all peripheral AVF stenosis
- Where
- Singapore
- Volunteers
- 94 people
- Sponsor
- Singapore General Hospital
Coronary In-stent Restenosis, Coronary Artery Disease
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
This prospective, multicenter, randomized, open-label, noninferiority trial will compare a sirolimus-coated balloon (SeQuent SCB) with a paclitaxel-coated balloon (RESTORE DEB) in 106 adults with recurrent coronary in-stent…
- Trial name
- SPRIT (NCT07920055)
- Testing
- SeQuent SCB sirolimus-coated balloon, RESTORE DEB paclitaxel-coated balloon
- Where
- China
- Volunteers
- 106 people
- Sponsor
- Sir Run Run Shaw Hospital
Percutaneous Coronary Intervention (PCI), Drug Coated Balloon
Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety…
- Conditions
- Percutaneous Coronary Intervention (PCI), Drug Coated Balloon, Paclitaxel, CAD - Coronary Artery Disease
- Trial name
- RECORD-DCB (NCT07231835)
- Where
- Netherlands
- Volunteers
- 3,000 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)