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

Not Applicable

Completed

• Conditions: Coronary Disease
• Interventions: Other: Drug eluting stent; Other: Durg coated balloon

• Registration Number: NCT04753827
• Lead Sponsor: Henan Institute of Cardiovascular Epidemiology

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.

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 Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Study Start: 2021-10-03
• Primary Completion: 2022-07-20
• Study Completion: 2022-07-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group Stent+DCB	Drug eluting stent	The MV was stented and the SB were treated with just drug-coated balloon(DCB)
Experimental Group Stent only	Drug eluting stent	Stents were implanted in MV and SB respectively, and DKcrush or Culotte technology was selected according to the lesion characteristics.
Experimental Group Stent+DCB	Durg coated balloon	The MV was stented and the SB were treated with just drug-coated balloon(DCB)
Experimental Group L-Sandwich	Drug eluting stent	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
Experimental Group L-Sandwich	Durg coated balloon	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

Primary Outcome Measures

Name	Time	Method
main vessel late lumen loss	6 months	main vessel late lumen loss
Side branch late lumen loss	6 months	Side branch late lumen loss

Secondary Outcome Measures

Name	Time	Method
Target lesion failure rate	6 months	Cardiac death,Target vessel MI,Target lesion revascularization

Trial Locations

Locations (1)

Fuwai central China cardiovascular Hospital; 🇨🇳 Zhengzhou, Henan, China