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

NCT07552194 | Not Yet Recruiting DMC

• 2 other identifiers: MMU-0326-2026-28R-2026-03-01
• Study Type: interventional
• Target: 272
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

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

Keywords

coronary bifurcation stenting; drug eluting balloon; true coronary bifurcation lesion; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• safety and efficacy

  all cause death, myocardial infarction, clinically driven target lesion revascularization

  from enrollment to the end of observation at 12 months

Study Arms (2)

drug eluting balloon arm

EXPERIMENTAL

only drug eluting balloon will be used for percutaneous coronary bifurcation treatment

Device: Balloon Angioplasty with or without drug administration

Stenting arm

ACTIVE COMPARATOR

Device: Balloon Angioplasty with or without drug administration

Interventions

Balloon Angioplasty with or without drug administration DEVICE

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

Stenting arm; drug eluting balloon arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avtandil M. Babunashvili: lead
• I.M. Sechenov First Moscow State Medical University: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Avtandil Babunashvili, professor

  clinic CELT

  STUDY CHAIR

• David Iosseliani, professor

  First Moscow State Medical University

  STUDY CHAIR

Central Study Contacts

Avtandil Babunashvili, professor

CONTACT

+79857673186; avtandil.babunashvili@gmail.com

Djamil Asadov, PhD

CONTACT

+79104537353; asadov_djamil@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded about final treatment strategy. Independent study outcomes assessor also should be blinded and only the identification code is provided
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assocaite Professor at the faculty of Interventional Angiology and cardiology First Moscow Medical University (Sechenov University)

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): June 2, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): February 20, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: request should be sent by email to study chairs including information about the goal of planned analysis and data sharing agreement must be signed