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

Sponsor
Henan Institute of Cardiovascular Epidemiology (Other)
Overall Status
Completed
CT.gov ID
NCT04753827
Collaborator
(none)
107
1
3
9.5
11.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Drug eluting stent
  • Other: Durg coated balloon
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three different strategies for true bifurcationThree different strategies for true bifurcation
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
Actual Study Start Date :
Oct 3, 2021
Actual Primary Completion Date :
Jul 20, 2022
Actual Study Completion Date :
Jul 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group Stent only

Stents were implanted in MV and SB respectively, and DKcrush or Culotte technology was selected according to the lesion characteristics.

Other: Drug eluting stent
Put a Drug eluting stent in the blood vessel

Experimental: Experimental Group Stent+DCB

The MV was stented and the SB were treated with just drug-coated balloon(DCB)

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

Experimental: Experimental Group L-Sandwich

Stents were implanted in the MV and the shaft of side branch SB respectively, then a DCB was applied to the ostium of the SB

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

Outcome Measures

Primary Outcome Measures

  1. main vessel late lumen loss [6 months]

    main vessel late lumen loss

  2. Side branch late lumen loss [6 months]

    Side branch late lumen loss

Secondary Outcome Measures

  1. Target lesion failure rate [30days]

    Cardiac death,Target vessel MI,Target lesion revascularization

  2. Target lesion failure rate [6 months]

    Cardiac death,Target vessel MI,Target lesion revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fuwai central China cardiovascular Hospital Zhengzhou Henan China

Sponsors and Collaborators

  • Henan Institute of Cardiovascular Epidemiology

Investigators

  • Study Chair: Muwei Li, MD, FF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Henan Institute of Cardiovascular Epidemiology
ClinicalTrials.gov Identifier:
NCT04753827
Other Study ID Numbers:
  • HenanICE202102
First Posted:
Feb 15, 2021
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022