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DCB vs. DES in Bifurcation Coronary Lesions

NCT06551662 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2025-12-04

No results posted yet for this study

Summary

This is an investigator-driven prospective, multicentric, international, randomized clinical study, in an open-label randomized fashion, where patients with bifurcation coronary artery disease (Medina: 111,101,011,001) in vessels with diameter \>2.0 (visual estimation) and with a clinical indication to PCI, will be enrolled. After successful predilatation (with any tool deemed useful), patients will be randomized 1:1:1 to SCB, PCB or standard treatment with DES for bifurcation native vessel disease. All patients with a clinical indication for PCI, both stable coronary artery disease and acute coronary syndrome, will be enrolled.

Before participating all the candidates will be clearly informed about the study, including the possible risks and benefits, and will be asked to provide a written informed consent. Subjects will be instructed that may not meet the general criteria for inclusion or the angiographic criteria, or that may have at least one exclusion criteria, and then be excluded from the study (screening failure), even after informed consent is obtained.

Consecutive patients who meet at least one of the inclusion criteria and none of the exclusion criteria, will participate to the study. After randomization, the procedure will consist in standard coronary angioplasty following international guidelines/consensus documents and as per local practice. If the patient has been randomized to SCB or PCB, it is mandatory to adequately prepare the lesion.

Conditions

Interventions

DEVICE

Paclitaxel drug-coated balloons

Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

DEVICE

Sirolimus drug-coated balloons

Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

DEVICE

New generation drug-eluting stent

Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

Sponsors & Collaborators

  • Fondazione Ricerca e Innovazione Cardiovascolare ETS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-02-01
Completion
2028-02-01

Countries

  • Italy
  • Poland
  • Romania
  • Singapore

Study Locations

More Related Trials

Entities

Diseases

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 NCT06551662 on ClinicalTrials.gov