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Completed

NCT Number: NCT04753827

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

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

About this study

This is a study to evaluate the application of L-Sandwich in true bifurcation coronary artery disease.All eligible patients were randomly divided into three groups: experimental group 1: dual stent group: both main vessel(MV) and side branch(SB) were stented, and DK-Crush or Culotte were performed according to different pathological characteristics. Experimental group 2: single stent + drug-coated balloon（DCB）: stent was implanted in the MV, and only drug balloon was used in the SB.Experimental group 3: L-Sandwich : stent was implanted in the MV, and the branch was implanted 3-5mm away from the ostium，and the DCB was implanted in the ostium of the branch.IVUS+ angiography was used to guide the operation and evaluate the outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with true bifurcation disease with SB lesion length>25mm

Exclusion criteria

  • SB diameter<2.5mm
  • presence of cardiogenic shock or cardiopulmonary resuscitation
  • Expected survival <1 year
  • Allergy to indexed medications
  • Intolerable to dual antiplatelet therapy
  • pregnant
  • Severe calcification needing rotational atherectomy

Treatment and study plan

Drug eluting stent

Other

Put a Drug eluting stent in the blood vessel

Durg coated balloon

Other

Put a Durg coated balloon in the blood vessel

Primary outcomes

  1. main vessel late lumen loss

    Time frame: 6 months

    main vessel late lumen loss

  2. Side branch late lumen loss

    Time frame: 6 months

    Side branch late lumen loss

Secondary outcomes

  1. Target lesion failure rate

    Time frame: 30days

    Cardiac death,Target vessel MI,Target lesion revascularization

  2. Target lesion failure rate

    Time frame: 6 months

    Cardiac death,Target vessel MI,Target lesion revascularization

Sponsors and collaborators

Lead sponsor

Henan Institute of Cardiovascular Epidemiology

Other

Registry information

Acronym: L-Sandwich

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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