Clinical trials: Bifurcation Coronary Disease
Coronary Artery Disease
Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
Treatment of bifurcation coronary lesions may be challenging, and the best technique to be used in these settings remains to be established.
- Trial name
- TIPTAP-I (NCT03714750)
- Testing
- DK crush, Reverse TAP
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Tommaso Gori
Coronary Artery Disease
COmplex Bifurcation PCI: AXXESS Device + Absorb BVS, vs Modified T Stenting With Absorb BVS
Comparison of healing responses after treatment of complex bifurcation lesions with a dedicated bifurcation device (Axxess™ Biolimus Eluting Coronary Bifurcation Stent System + Absorb BVS in the distal branches) versus the…
- Trial name
- COBRAII (NCT02628288)
- Testing
- Coronary Bifurcation PCI
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Coronary Artery Disease, Death
Long-term Outcomes of Patients After Coronary Bifurcation Stenting
The purpose of this study is to assess the long-term clinical outcomes after stenting bifurcation coronary artery lesions, and to determine whether simple or more complex techniques are associated with a better clinical outcome.
- Conditions
- Coronary Artery Disease, Death, Myocardial Infarction
- Trial name
- NCT00325884
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- VA Boston Healthcare System
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
Comparison of Double-kissing Crush and Double-kissing Culotte Stenting
True bifurcation lesions (TBLs) are not rare clinical conditions and may be associated with adverse cardiovascular outcomes due to their complex anatomy and the variety of interventional therapy.
- Trial name
- NCT04789161
- Testing
- double kissing crush stenting, double kissing culotte stenting
- Where
- Turkey (Türkiye)
- Volunteers
- 200 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Disease
The European Bifurcation Club Left Main Study
The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.
- Trial name
- EBC MAIN (NCT02497014)
- Testing
- 1 Stent, 2 Stents
- Where
- 24 sites in Denmark, France and 6 more
- Volunteers
- 450 people
- Sponsor
- European Cardiovascular Research Center
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
PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease
1. To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease 2.
- Trial name
- NCT02384629
- Testing
- OCT-guided PCI with AXXESS stent, OCT-guided PCI with conventional DES (Biomatrix flex stent), Angio-guided PCI with AXXESS stent
- Sponsor
- Yonsei University
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 (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 Artery Disease, Atherosclerosis
Drug-eluting Balloon in Bifurcations Trial
The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of: 1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Stable Angina, Unstable Angina
- Trial name
- DEBIUT (NCT00857441)
- Testing
- Drug eluting balloon, Liberté, PTCA balloon catheter
- Where
- 3 sites in Belgium, Netherlands
- Volunteers
- 120 people
- Sponsor
- UMC Utrecht
Coronary Artery Disease
Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch
Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.
- Trial name
- CROSS (NCT00694005)
- Testing
- kissing balloon, without kissing balloon angioplasty "leave alone"
- Where
- 11 sites in South Korea
- Volunteers
- 504 people
- Sponsor
- Seung-Jung Park
Stable Angina
Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques
Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the…
- Trial name
- MV:main branch (NCT02137486)
- Where
- Taiwan
- Volunteers
- 214 people
- Sponsor
- Taipei City Hospital
Cardiovascular Disease, Coronary Artery Occlusion
Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients
The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomi™ sirolimus eluting coronary stent system (Ultimaster Nagomi™) in complex PCI…
- Conditions
- Cardiovascular Disease, Coronary Artery Occlusion, Ischemic Heart Disease
- Trial name
- NAGOMI COMPLEX (NCT05705973)
- Testing
- Ultimaster Nagomi™
- Where
- 52 sites in Austria, Belgium and 11 more
- Volunteers
- 3,000 people
- Sponsor
- Terumo Europe N.V.
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 Heart Disease
The Study of Active Transfer of Plaque Technique for Non-Left Main Coronary Bifurcation Lesions
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions.
- Trial name
- NCT02768116
- Testing
- Sirolimus Drug-eluting Stent via Active Transfer of Plaque, Sirolimus Drug-eluting Stent implantation via Provisional T Stenting
- Volunteers
- 316 people
- Sponsor
- Beijing Anzhen Hospital
Coronary Artery Disease, DCB
DCB vs. DES in Bifurcation Coronary Lesions
This is an investigator-driven prospective, multicentric, international, randomized clinical study, in an open-label randomized fashion, where patients with bifurcation coronary artery disease (Medina: 111,101,011,001) in vessels…
- Trial name
- PICCOLETO V (NCT06551662)
- Testing
- Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons, New generation drug-eluting stent
- Where
- 17 sites in Italy, Poland and 2 more
- Volunteers
- 321 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
Left Main Coronary Artery Disease
Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions
The Crush technique has evolved significantly since its introduction to the literature by Colombo et al in 2003, with multiple iterations including mini-crush (MC) and double kissing-crush (DKC) stenting techniques.
- Trial name
- NCT06546748
- Where
- Turkey (Türkiye)
- Volunteers
- 531 people, healthy volunteers welcome
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Coronary Artery Disease
Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases
The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases.
- Trial name
- NCT03714802
- Testing
- Szabo T-Stenting Technique, T-Stenting Technique
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Shanghai Zhongshan Hospital