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"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions

NCT04753827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2022-08-05

No results posted yet for this study

Summary

The treatment of coronary bifurcation lesions continue to remain challenges. Due to the complexity of the anatomical structure and the limitations of imaging, there are poor attachment and under-expansion of the stent at the branch ostium, which causes in-stent thrombosis and restenosis. The delayed re-endothelialization arise from multi-layer stents. The one-stent strategy causes the displacement of the plaques and ridges of the branch ostium, and thus insufficient blood flow to the branches. The "L-sandwich" strategy, stents were implanted in the main vessel(MV) and the shaft of side branch(SB) respectively, then a drug-coated balloon(DCB) was applied to the ostium of the SB, to improve the tedious operation process in true bifurcation lesions and reduce postoperative complications. The purpose of this study was to explore the feasibility, safety, and efficacy of the "sandwich" strategy.

Conditions

  • Coronary Disease

Interventions

OTHER

Drug eluting stent

Put a Drug eluting stent in the blood vessel

OTHER

Durg coated balloon

Put a Durg coated balloon in the blood vessel

Sponsors & Collaborators

  • Henan Institute of Cardiovascular Epidemiology

    lead OTHER

Principal Investigators

  • Muwei Li, MD · FF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-03
Primary Completion
2022-07-20
Completion
2022-07-20

Countries

  • China

Study Locations

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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 NCT04753827 on ClinicalTrials.gov