Clinical trials: Bifurcation Coronary Disease
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry
Percutaneous coronary intervention (PCI) of complex coronary bifurcation lesions frequently requires an upfront two-stent strategy.
- Conditions
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Bifurcation Coronary Artery Disease
- Trial name
- NCT07849335
- Testing
- Percutaneous Coronary Intervention with Minicrush
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- San Luigi Gonzaga Hospital
Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.
- Conditions
- Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Bifurcation of Coronary Artery, Multi Vessel Coronary Artery Disease
- Trial name
- DYNAMITE (NCT05464147)
- Testing
- DynamX Drug-Eluting Coronary Bioadaptor System
- Where
- Italy
- Volunteers
- 55 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease, Coronary Bifurcation Lesions
Progress Bifurcation Global Registry
Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches.
- Trial name
- NCT05100992
- Testing
- Percutaneous Coronary Interbention
- Where
- United States
- Volunteers
- 4,000 people
- Sponsor
- Minneapolis Heart Institute Foundation
Coronary Artery Disease (CAD), Chronic Coronary Syndrome
"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI
This is a prospective, randomized, controlled trial comparing two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery (LM): an intravascular ultrasound (IVUS)-guided approach…
- Conditions
- Coronary Artery Disease (CAD), Chronic Coronary Syndrome, Left Main Coronary Artery Disease, Coronary Bifurcation Lesion
- Trial name
- EYE-IVUS LM (NCT07711106)
- Testing
- IVUS-Guided LM PCI, "Trained Eye" (Angiography-Guided) LM PCI
- Where
- Russia
- Volunteers
- 50 people
- Sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Coronary Bifurcation Lesion, Coronary Artery Disease (CAD)
Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions
Coronary artery disease is a leading cause of mortality and morbidity globally. The left coronary artery system is critically important due to its supply of a large area of myocardium.
- Conditions
- Coronary Bifurcation Lesion, Coronary Artery Disease (CAD), Left Main Coronary Artery Stenosis
- Trial name
- NCT07596706
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 1,000 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
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.
Coronary Artery Disease (CAD), Coronary Bifurcation Lesion
Stenting Versus Drug Eluting Balloons Only in Treatment of Coronary Bifurcation Lesion (ROBUST Study)
The goal of this clinical trial is to learn immediate and follow up results of percutaneous treatment of coronary bifurcation lesion using drug eluting balloons (DEB) only in patients with chronic coronary syndrome (CCS).
- Conditions
- Coronary Artery Disease (CAD), Coronary Bifurcation Lesion, Coronary Stenting, Drug Eluting Balloon
- Trial name
- ROBUST (NCT07552194)
- Testing
- Balloon Angioplasty with or without drug administration
- Volunteers
- 272 people
- Sponsor
- Avtandil M. Babunashvili
Coronary Arterial Disease (CAD), Restenosis, Coronary
Restrospective Analysis of MACE in Patients Treated With Drug-elluting Balloons.
Retrospective analysis of data collected in an institutional database of coronary interventions with use of drug-eluting balloons, with a prospective follow-up for major adverse cardiovascular events and living status.
- Conditions
- Coronary Arterial Disease (CAD), Restenosis, Coronary, Bifurcation Coronary Disease
- Trial name
- EASY-DEB (NCT06972225)
- Testing
- DEB
- Where
- Canada
- Volunteers
- 1,500 people
- Sponsor
- Olivier F. Bertrand
Coronary Artery Disease, Coronary Artery Disease (Left Main)
Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice
Coronary artery disease remains a leading cause of mortality worldwide and is commonly treated with percutaneous coronary intervention (PCI). Typically, PCI is guided by invasive coronary angiography (ICA).
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (Left Main), Chronic Total Occlusion (CTO), Bifurcation Coronary Artery Disease
- Trial name
- OPTIMIZE-PCI 2 (NCT07114393)
- Testing
- Liberal use of intracoronary imaging during complex PCI
- Where
- Netherlands
- Volunteers
- 11,092 people
- Sponsor
- Cathreine BV
Complex Left Main Bifurcation Stenosis, Left Main Coronary Artery Stenosis
COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.
Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial. Participants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).
- Conditions
- Complex Left Main Bifurcation Stenosis, Left Main Coronary Artery Stenosis, Coronary Bifurcation Stenosis
- Trial name
- COMPETE-LM (NCT07408674)
- Testing
- Angiolite Sirolimus-Eluting Stenting, Essential Pro Paclitaxel Drug-Eluting Balloon
- Volunteers
- 186 people
- Sponsor
- Rede Optimus Hospitalar SA
Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bfurcation Lesions
The Crush technique for coronary bifurcation lesions has evolved significantly since its introduction to the literature by Colombo et al. in 2003, with several iterations, including double kissing balloon inflation.
- Conditions
- Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI), Bifurcation Coronary Disease
- Trial name
- NCT06931574
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 300 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
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
Coronary Artery Disease, Bifurcation Lesion
Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion
Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural…
- Trial name
- NCT06166459
- Testing
- Drug-coated balloon combined with provisional drug-eluting stent implantation
- Volunteers
- 200 people
- Sponsor
- Xuzhou Third People's Hospital
Coronary Artery Disease, Coronary Bifurcation Lesion
Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy
The optimal treatment of coronary bifurcation lesions is complex and remains subject of current research. There is ongoing debate about the optimal strategy for bifurcations with upfront two-stent strategy or provisional…
- Trial name
- Hybrid DEB (NCT05731687)
- Testing
- Hybrid DEB approach with drug-eluting balloon, Two-stent strategy
- Where
- Netherlands
- Volunteers
- 500 people
- Sponsor
- Cathreine BV
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.
Coronary Diseases, Left Main Coronary Artery Disease
Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China
This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai…
- Conditions
- Coronary Diseases, Left Main Coronary Artery Disease, Bifurcation Lesions
- Trial name
- NCT04641468
- Testing
- DCB
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xuzhou Third People's Hospital
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, Bifurcation Lesions
Efficacy Study of Kissing Drug-Eluting Balloons in Coronary Bifurcation Lesions
KISSING DEBBIE's aim at assessing angiographic and clinical outcomes of provisional treatment of coronary bifurca6on lesions according to TAP sten6ng with BMS and final kissing DEB
- Trial name
- KISSING DEBBIE (NCT01009996)
- Testing
- Kissing DEB
- Where
- Italy
- Sponsor
- Ospedale Santa Maria Goretti
Stent Restenosis, Stent Thrombosis
veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization.
- Conditions
- Stent Restenosis, Stent Thrombosis, Left Main Coronary Artery Disease, Coronary Bifurcations
- Trial name
- RAIN (NCT03544294)
- Testing
- Xience alpine, ultimaster, resolute onyx, synergy
- Where
- Italy
- Volunteers
- 2,800 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Myocardial Ischemia, Ischemia
Bifurcation ABSORB OCT Trial
The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold provisional strategy in the treatment of (a)…
- Conditions
- Myocardial Ischemia, Ischemia, Coronary Disease, Heart Diseases
- Trial name
- BISORB OCT (NCT02928198)
- Testing
- ABSORB BVS
- Where
- Netherlands
- Volunteers
- 3 people
- Sponsor
- J.J. Wykrzykowska