Clinical trials: Bifurcation Coronary Disease
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
Nordic Bifurcation Stent Technique Study (BIF II)
This is a study of crush- or culotte stenting of bifurcation lesions using drug eluting stents. This is a randomized Nordic multicenter study including 400 patients with angina pectoris with clinical angiographic follow-up.
- Trial name
- BIF II (NCT00292305)
- Testing
- Percutaneous coronary intervention
- Where
- Denmark
- Volunteers
- 425 people
- Sponsor
- Aarhus University Hospital Skejby
Unprotected Left Main Coronary Artery Disease
Comparison of HYBRID Versus Two-Stent Strategies in Unprotected True Left MAIN Bifurcation
The number of deaths from heart disease is rising globally, particularly in developing countries. This condition involves the narrowing of arteries that supply blood to the heart.
- Trial name
- HYBRID MAIN (NCT07159737)
- Testing
- Two-stent strategy, Hybrid Strategy
- Volunteers
- 800 people
- Sponsor
- Hospital Sultanah Bahiyah
Coronary Artery Disease
Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation
The Axxess™ Biolimus A9™ Eluting Coronary Bifurcation Stent System (AXXESS System; Biosensors, International, Morges, Switzerland) is a dedicated bifurcation stent, designed to cover the lesion at the level of the carina.
- Trial name
- CARINAX (NCT02486315)
- Testing
- AXXESS stent
- Volunteers
- 326 people
- Sponsor
- Clinica Mediterranea
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, 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 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
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 Artery Disease
Optimal Stenting Strategy For True Bifurcation Lesions
It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.
- Trial name
- PERFECT (NCT00693251)
- Testing
- Crush technique, provisional T stenting
- Where
- 12 sites in South Korea
- Volunteers
- 420 people
- Sponsor
- Seung-Jung Park
Coronary Artery Disease
The Study of the Crushing Technique Application Using SES in Coronary Bifurcations.
The objective of this study is to compare the safety and effectiveness of two different approaches to treat bifurcational lesions with CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent , Cordis Corp): a) the…
- Trial name
- CACTUS (NCT00749424)
- Testing
- SES
- Where
- Italy
- Volunteers
- 350 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease, Coronary Stenosis
Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness < 70 um) for coronary bifurcation lesions, left main disease…
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Stent Restenosis, Left Main Coronary Artery Disease
- Trial name
- ULTRA (NCT05205148)
- Testing
- Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Coronary Artery Disease
Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions?
How to use drug eluting stents (DES) in bifurcation lesions. A strategy of routine stenting of both main vessel and side branch versus a strategy of routine main vessel stenting and optional treatment of side branch.
- Trial name
- BIFI (NCT00376571)
- Testing
- Percutaneous coronary intervention
- Where
- Denmark
- Volunteers
- 413 people
- Sponsor
- Aarhus University Hospital Skejby
Coronary Stenosis
POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
The primary objective of this study is to study the safety and efficacy of the BiOSS LIM C with respect to Patient oriented Composite Endpoint (PoCE) at 12 months in a "real world" left-main bifurcation population and as compared…
- Trial name
- POLBOS-LM (NCT03508219)
- Testing
- BiOSS LIM C
- Where
- 15 sites in France, Italy and 1 more
- Volunteers
- 130 people
- Sponsor
- ECRI 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 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
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
Coronary Stenosis, Drug-coated Balloon
Bingo Drug-Coated Balloon in Real World
The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.
- Conditions
- Coronary Stenosis, Drug-coated Balloon, De Novo Stenosis, Coronary Artery Disease in Transplanted Heart Accelerated
- Trial name
- NCT04234893
- Where
- China
- Volunteers
- 805 people
- Sponsor
- Yinyi(Liaoning) Biotech 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
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 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