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

NCT07552194 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2026-04-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • Avtandil M. Babunashvili

    lead OTHER

Principal Investigators

  • Avtandil Babunashvili, professor · clinic CELT

  • David Iosseliani, professor · First Moscow State Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-02
Primary Completion
2027-12-20
Completion
2028-02-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07552194 on ClinicalTrials.gov