Clinical trials: Bifurcation Lesion
Coronary Artery Disease
Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
TRYTON Post Approval Study (PAS) of the Tryton Side Branch Stent
- Trial name
- PAS (NCT03318796)
- Testing
- Coronary Artery Stenting
- Where
- United States
- Volunteers
- 335 people, healthy volunteers welcome
- Sponsor
- Tryton Medical, Inc.
Coronary Atherosclerosis of Native Coronary Artery, Bifurcation Lesions: de Novo Lesions of the Main and Side Branch of Native Coronary Artery
Prospective, Single Blind, Rand Controlled Study to Evaluate the Safety & Effectness of Tryton Side Branch Stent Used With DES Treatmt of de Novo Bifurcation Lesions in MB & SB in Native Coronaries
The Tryton Side Branch Stent System has been designed to address the procedural difficulty surrounding treatment of bifurcation lesions and to ensure patency of the side branch with similar performance capabilities (e.g.…
- Trial name
- TRYTON (NCT01258972)
- Testing
- Tryton Side Branch Stent with main branch DES, POBA
- Where
- United States
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Tryton Medical, Inc.
Coronary Bifurcation Lesions
Sirolimus DEB in Coronary Bifurcation Lesions
The purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions.
- Trial name
- NCT04896177
- Testing
- Sirolimus drug-eluting coronary balloon catheter, Paclitaxel drug-eluting coronary balloon catheter
- Where
- China
- Volunteers
- 280 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Cardiovascular Diseases
Safety Study to Assess the Feasibility of Use in Humans of the TAXUS Petal Bifurcation Coronary Stent System
The purpose of this study is to determine the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System in the treatment of de novo lesions in native coronary arteries…
- Trial name
- NCT00497367
- Testing
- Percutaneous Coronary Intervention (PCI) TAXUS Petal
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 28 people
- Sponsor
- Boston Scientific Corporation
Coronary Disease
Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in Side Branches of de Novo Bifurcation Lesions (DEBSIDE)
The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native coronary arteries.
- Trial name
- DEBSIDE (NCT01485081)
- Testing
- Danubio paclitaxel-eluting balloon
- Where
- 7 sites in France
- Volunteers
- 52 people
- Sponsor
- MINVASYS
Percutaneous Coronary Intervention
The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions
To evaluate the safety and effectiveness of paclitaxel-eluting coronary artery balloon dilation catheter (DIOR) in revascularization of coronary bifurcation lesions compared with paclitaxel-eluting balloon (Bingo), and to provide…
- Trial name
- BEYOND-II (NCT03820622)
- Testing
- Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR), Paclitaxel-Eluting Balloon (Bingo)
- Where
- 13 sites in China
- Volunteers
- 220 people
- Sponsor
- CCRF Inc., Beijing, China
Angina Pectoris, Angina, Unstable
Intravascular Near Infrared Spectroscopy (NIRS) Bifurcation - Lipid Core Plaque Shift Study
This pilot study is going to examine the hypothesis that in coronary arteries, soft lesions that contain lipid cores, but are not calcified or fibrotic and are located in proximity to side branches, are associated with side…
- Conditions
- Angina Pectoris, Angina, Unstable, Atherosclerosis, Coronary Artery Disease
- Trial name
- NCT00905671
- Testing
- LipiScan Coronary Imaging Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Infraredx
Coronary Angioplasty, Bifurcation Coronary Artery Disease
Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)
This first in human feasibility study is designed to evaluate the feasibility MD-SBA DES in subjects undergoing percutaneous coronary intervention (PCI) to treat bifurcation lesions.
- Conditions
- Coronary Angioplasty, Bifurcation Coronary Artery Disease, Ischemic Heart Disease (IHD), Percutaneous Coronary Intervention (PCI)
- Trial name
- NCT07649798
- Testing
- MD-SBA DES System
- Where
- Paraguay
- Volunteers
- 13 people
- Sponsor
- Advanced Bifurcation Systems Inc.
CAD
Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice
The study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications: In-stent…
- Trial name
- NCT02853994
- Volunteers
- 500 people
- Sponsor
- MINVASYS
Coronary Disease
Keep bIfurcation Single Stenting Simple
KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection
- Trial name
- KISS (NCT04285372)
- Testing
- Side branch protection/ballooning, No side branch protection/ballooning
- Where
- 20 sites in France, Italy and 4 more
- Volunteers
- 596 people
- Sponsor
- Ceric Sàrl
Coronary Atherosclerosis
Bifurcation Lesion Analysis and STenting / BLAST
The purpose of this research study is to determine if Intravascular Ultrasound (IVUS) grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the location, amount, and type of a blockage than angiogram…
- Trial name
- BLAST (NCT02316782)
- Testing
- Blinded IVUS assessment, Nonblinded IVUS
- Where
- 10 sites in United States, Denmark and 6 more
- Volunteers
- 195 people
- Sponsor
- Volcano Corporation
Coronary Bifurcation Lesions
ACOART SCB BIF: Treatment of Coronary Bifurcation Lesion by Sirolimus Coated Balloon vs Paclitaxel Coated Balloon
The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon.
- Trial name
- NCT04899583
- Testing
- Sirolimus Coated Balloon Catheter, a Paclitaxel Coated Balloon Catheter
- Where
- China
- Volunteers
- 230 people
- Sponsor
- Acotec Scientific Co., Ltd
Coronary Artery Disease
Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions
Bingo drug-eluting balloon versus a drug-eluting stent for coronary bifurcation lesions: a prospective, multi-center, randomized, non-inferiority trial
- Trial name
- NCT06441539
- Testing
- Bingo® Paclitaxel coated balloon, Xience® Alpine Everolimus Eluting Coronary Stent System
- Volunteers
- 218 people
- Sponsor
- Yinyi(Liaoning) Biotech Co., Ltd.
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.
Bifurcation Lesion, Coronary Artery Disease
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique
Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.
- Trial name
- insProvisional (NCT03780192)
- Testing
- Inspiron Sirolimus Eluting Stent
- Where
- Brazil
- Volunteers
- 80 people
- Sponsor
- Scitech Produtos Medicos SA
Coronary Artery Disease, Myocardial Ischemia
AngioSculpt® Coronary Bifurcation Study
The purpose of this study is to evaluate a new angioplasty catheter, AngioSculpt® for the treatment of bifurcation lesions (blockages occurring at branch points) in coronary arteries.
- Trial name
- AGILITY (NCT00686647)
- Testing
- AngioSculpt® Scoring Balloon Catheter, AngioSculpt Scoring Balloon Catheter
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- AngioScore, Inc.
Coronary Bifurcation Lesion
Efficacy and Safety of Sirolimus-Coated Spiral Balloon for Coronary Bifurcation Lesions
This is a multicenter, prospective randomized controlled study to evaluate the safety and effectiveness of Sirolimus-coated spiral balloon (SuperFlow®) versus Paclitaxel-coated balloon (Bingo™) in the treatment of coronary…
- Trial name
- NCT06618248
- Testing
- Sirolimus coated balloon angioplasty, Paclitaxel coated balloon angioplasty
- Where
- China
- Volunteers
- 280 people
- Sponsor
- Dongguan TT Medical
Coronary Artery Disease, Bifurcation Lesion
Using 3D Imaging to Optimize Bifurcation Stenting
The primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with angiographic guidance by measuring incomplete…
- Trial name
- NCT02972489
- Testing
- 3D OFDI guidance arm, Angio guidance arm
- Where
- 2 sites in Japan, Netherlands
- Volunteers
- 106 people
- Sponsor
- Increase Co., Ltd.
Coronary Artery Disease
Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions
This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.
- Trial name
- BABILON (NCT01278186)
- Testing
- Balloon angioplasty, Stent implantation
- Where
- 9 sites in Spain
- Volunteers
- 190 people
- Sponsor
- B.Braun Surgical SA
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.