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

Coronary Disease Clinical Trial

— L-Sandwich  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753827
• Other study ID #: HenanICE202102
• Status: Completed
• Phase: N/A
• Start date: October 3, 2021
• Est. completion date: July 20, 2022

Study information

• Verified date: August 2022
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Other:
• Drug eluting stent
Put a Drug eluting stent in the blood vessel
• Durg coated balloon
Put a Durg coated balloon in the blood vessel

Locations

Country	Name	City	State
China	Fuwai central China cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	main vessel late lumen loss	main vessel late lumen loss	6 months
Primary	Side branch late lumen loss	Side branch late lumen loss	6 months
Secondary	Target lesion failure rate	Cardiac death,Target vessel MI,Target lesion revascularization	30days
Secondary	Target lesion failure rate	Cardiac death,Target vessel MI,Target lesion revascularization	6 months