Coronary Bifurcation Lesion

6

Review clinical trials related to Coronary Bifurcation Lesion. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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). Researchers will compare endovascular treatment using solely DEB to stenting of coronary bifurcation lesion. The main questions it aims to answer are: * What is immediate and follow up clinical and angiographic results of endovascular treatment of coronary bifurcation lesion using DEB in patients with CCS? * Is efficacy and safety of endovascular treatment of coronary bifurcation lesion using DEB only in patients with CCS non inferior to compare stenting of aforementioned lesion which is contemporary recommended standard of care? Participants will: * Take prescribed medication before and after initial procedure during whole observation period (12 months) * Visit the clinic at 1, 6 and 12 months after the initial procedure for checkup, noninvasive tests and control angiography at 12 months follow up * Inform researchers about all adverse events that might be occur during follow up observation period

Participants needed: 272
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Avtandil M. BabunashviliUpdated: Apr 27, 2026
Eligibility criteria

Patients with CCS with documented myocardial ischemia in area supplying by the t... [+7]

Patients with a single remaining artery supplying a large area of myocardium at... [+20]

Status: Not yet recruiting

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. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.

Participants needed: 750
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ceric SàrlUpdated: Feb 14, 2025
Eligibility criteria

True non-left main bifurcation disease with both MV and SB involvement (i.e Medi... [+7]

Patients <18 years old [+11]

Status: Recruiting

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 bifurcation lesions.

Participants needed: 280
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Dongguan TT MedicalUpdated: Oct 1, 2024Locations: 1
Eligibility criteria

Patients aged between 18 and 85 years, regardless of gender. [+7]

Patients with bleeding disorders or active gastrointestinal ulcers, those who ha... [+15]

Status: Recruiting

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 one-stent strategy. Current European Society of Cardiology (ESC) guidelines advise a provisional approach with optional stepwise two-stent strategy in case of suboptimal result of the side branch (SB). However, a two-stent strategy (either upfront and stepwise) caries technical difficulties and is associated with increased procedure duration and costs and higher exposure of the patient to radiation and contrast. Therefore there is upcoming interest in the use of a drug-eluting balloon (DEB) in the side branch of bifurcation lesions after provisional approach. Drug-eluting balloons are conventional semi-compliant angioplasty balloons covered with an anti-proliferating drug, which is released into the vessel wall during inflation. Several small pilot studies have successfully investigated a hybrid approach with use of DEB in addition to the provisional strategy. This hybrid approach has shown to be safe and feasible, however no large trials have been performed comparing this with current two-stent bifurcation strategies. The aim of this randomized controlled, single blinded, multicenter trial is to investigate whether a hybrid DEB approach is non-inferior to a stepwise provisional two-stent strategy in patients with de novo bifurcation lesions and a suboptimal result of the SB after provisional approach. Patients included in this study will receive PCI using provisional approach (implantation of drug-eluting stent (DES) in the main branch). Patients with an unsatisfactory result of the SB after provisional PCI (≥ 70% residual stenosis and/or diminished flow \< Thrombolysis in Myocardial Infarction (TIMI) III) will be randomized in a 1:1 ratio to receive the Hybrid DEB approach or the two-stent strategy. Patients with a satisfactory result of the side branch after provisional PCI will be included in a registry. Follow-up will be performed at 12 months and at the anticipated median 2 year follow-up with a minimum follow-up of 1 year in each subject by either a phone call or outpatient clinic visit. During follow-up information regarding cardiovascular drug use, hospitalizations, invasive and non-invasive diagnostic tests, angina status and SAE's is obtained.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Cathreine BVUpdated: Dec 15, 2023Locations: 1
Eligibility criteria

Significant de novo bifurcation lesion (main vessel and side branch diameter ≥ 2... [+3]

Unstable clinical condition [+7]

Status: Not yet recruiting

LATAM Bif Registry

The LATAM Bif Registy is an international and prospective registry of percutaneous coronary interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to investigate the current state and long-term outcomes of PCI in this complex subset of coronary lesions in Latin America.

Participants needed: 5,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: LATAM Bifurcation ClubUpdated: Jul 15, 2020
Eligibility criteria

Age >= 18 years [+2]

Protected left main disease in patients with previous CABG [+1]

Status: Recruiting

International Bifurcation Study

The IBS registry is an observational, multi-center, real-world registry of stenting in coronary bifurcation lesions that will collect information on procedures and outcomes from various participating centers. The aim of this registry is to investigate long-term clinical results and predictors of adverse outcomes after PCI for coronary bifurcation lesions among various participating centers.

Participants needed: 5,000
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: Meshalkin Research Institute of Pathology of CirculationUpdated: Mar 11, 2019Locations: 1Duration: 5 Years
Eligibility criteria

Age ≥ 18 years [+1]

Patient refused informed consent to participate in the registry