Clinical trials: Bifurcation, open to volunteers
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, 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
Unruptured Intracranial Aneurysm, Intracranial Bifurcation Aneurysm
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms
This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms.
- Conditions
- Unruptured Intracranial Aneurysm, Intracranial Bifurcation Aneurysm, Wide-Neck Aneurysm
- Trial name
- FD-SAC BAS (NCT07754188)
- Testing
- Flow Diverter, Stent-Assisted Coiling
- Where
- 3 sites in China
- Volunteers
- 274 people
- Sponsor
- Nanfang Hospital, Southern Medical University
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
Unruptured Intracranial Wide-neck Bifurcation Aneurysms
Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)
Brief Summary： The goal of this clinical trial is to compare whether the traditional approach (stent-assisted coiling) is associated with a lower complication rate than flow diverter (Pipeline™) treatment for unruptured…
- Trial name
- FD-BWA (NCT07707076)
- Testing
- Flow Diverter Group, Stent Assisted Coiling Group
- Where
- China
- Volunteers
- 266 people
- Sponsor
- Nanfang Hospital, Southern Medical University
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 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
Saccular and Fusiform Aneurysms, Pseudoaneurysm
Targeting Real World Usage In Stroke Treatment
TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC…
- Conditions
- Saccular and Fusiform Aneurysms, Pseudoaneurysm, Vascular Dissection, Perforation
- Trial name
- TRUST (NCT07474935)
- Testing
- Aneurysm Treatment with a Neurovascular Flow Diverter, Dissection Treatment with a Neurovascular Flow Diverter, Perforation Treatment with a Neurovascular Flow Diverter
- Where
- 13 sites in France, Germany and 3 more
- Volunteers
- 5,000 people
- Sponsor
- Phenox GmbH
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
Aneurysm Cerebral, Bifurcation
LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan
The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA).
- Conditions
- Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm
- Trial name
- NCT07259018
- Testing
- LuSeed Aneurysm Embolization System
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- LuSeed Vascular LTD.
Aneurysm Cerebral, Bifurcation
LUMENS-1 EU EFS CIP
The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA).
- Conditions
- Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm
- Trial name
- NCT06761365
- Testing
- LuSeed Aneurysm Embolization System
- Where
- 6 sites in Bulgaria, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- LuSeed Vascular LTD.
Root Perforation at the Bifurcation Area
Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
The goal of this clinical trial is to evaluate healing potentiality of MTA and bioceramics materials as a root perforation repair material.
- Trial name
- NCT06976411
- Testing
- MTA, Bioceramic putty
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mohamed Salah Elwakeel
Coronary Bifurcation Lesions
Coronary Bifurcations With Ischaemia and Flow Assessment
The coronary arteries are blood vessels that provide oxygen rich blood to the muscle of the heart. If these vessels become narrowed or blocked, this can lead to chest pain (called angina) or heart attacks.
- Trial name
- NCT06971718
- Testing
- Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- University of East Anglia
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 Bifurcation Lesions, Death
Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions
The mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions.
- Conditions
- Coronary Bifurcation Lesions, Death, Myocardial Infarction (MI), Stent Thrombosis
- Trial name
- NCT06880978
- Where
- Turkey (Türkiye)
- Volunteers
- 400 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 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, 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