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Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.

NCT06002932 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2025-02-10

No results posted yet for this study

Summary

\[The Purpose of the Clinical Study\] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions.

\[Hypothesis\] In this study, the researchers intend to verify the hypothesis that the 1-stent strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).

Conditions

Interventions

PROCEDURE

Procedure: planed 2-stent strategy

Procedure: planed 2-stent strategy

PROCEDURE

Procedure: provisional 1-stent plus DEB strategy

Procedure: provisional 1-stent plus DEB strategy

Sponsors & Collaborators

  • Saint Vincent's Hospital, Korea

    lead OTHER

Principal Investigators

  • Sung-Ho Her, MD. PhD. · St Vincent's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2028-07-31
Completion
2028-12-31

Countries

  • South Korea

Study Locations

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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 NCT06002932 on ClinicalTrials.gov