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NCT07552194

Stenting Versus Drug Eluting Balloons Only in Treatment of Coronary Bifurcation Lesion (ROBUST Study)

Sponsor: Avtandil M. Babunashvili

View on ClinicalTrials.gov

Summary

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

Official title: CompaRison of corOnary BifUrcation Treatment With and Without Stenting Using Only Drug eluTing Balloons (ROBUST Study)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

272

Start Date

2026-06-02

Completion Date

2028-02-20

Last Updated

2026-04-27

Healthy Volunteers

Conditions

Coronary Artery Disease (CAD)Coronary Bifurcation Lesion Coronary Stenting Drug Eluting Balloon

Interventions

DEVICE

Balloon Angioplasty with or without drug administration

stentless percutaneous endovascular treatment of coronary bifurcation lesion will be tested using drug eluting balloon intervention only

Inclusion Criteria: * Patients with CCS with documented myocardial ischemia in area supplying by the target coronary artery, not older than 80 years and with an expected life expectancy of at least 1 year * Patients with single- or multivessel disease and "true" (1.1.1; 1.1.0; and 0.1.1 according to the Medina classification) de novo bifurcation stenosis \> 50% and \<100% of the main coronary artery (excluding of the left main) or their large side branches. * Both main and side branches should be ≥ 2.0 mm and ≤ 4.5 mm in diameter (according to Quantitative coronary angiography - QCA or intravascular imaging) * Length of the main branch lesion should be no more than 30 mm * The total length of the side branch should be no more than 7 cm, and the side branch lesion length should be no more than 10 mm * Patients without hereditary coagulopathies * With a recent (at least 3 months) history of acute coronary syndrome (ACS) * Signed informed consent by patient to participate in the study Exclusion Criteria: * Patients with a single remaining artery supplying a large area of myocardium at risk, regardless of its caliber * Over 80 years of age * Bifurcation stenosis of the left main coronary artery and bifurcation lesions other than 1.1.1; 1.0.1, and 0.1.1 according to the Medina classification * The difference between the proximal and distal reference diameter of the main artery is \> 1 mm * Pregnancy or breastfeeding * Severe valvular heart disease requiring surgical or percutaneous intervention within 1 year * Life expectancy less than 1 year. * Chronic renal failure (glomerular filtration rate less than 30 ml/min) * Concomitant cancer * Heart failure \> NYHA class II * In-stent restenosis in bifurcation lesions after previously performed PCI * Presence of thrombus containing Lesion * Without concomitant chronic occlusion (bifurcation included in the chronic coronary occlusion (CTO)) * Patients at high bleeding risk (according to the PRECISE-DAPT score) * LV ejection fraction according to echocardiography ≤ 0.4 * Anemia (Hb \< 10 g/dL) * Thrombocytopenia and any coagulopathy * Episodes of significant bleeding and ongoing bleeding requiring modification of medical therapy * Acute coronary syndrome * PCI or coronary artery bypass grafting (CABG) performed according to clinical indications * Patient non-adherence to therapy, including antiplatelet and/or anticoagulant medications