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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Other: Drug eluting stent; Other: Durg coated balloon

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Fuwai Central China Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
main vessel late lumen loss	main vessel late lumen loss	6 months
Side branch late lumen loss	Side branch late lumen loss	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure rate	Cardiac death,Target vessel MI,Target lesion revascularization	30days
Target lesion failure rate	Cardiac death,Target vessel MI,Target lesion revascularization	6 months

Collaborators and Investigators

• Sponsor: Henan Institute of Cardiovascular Epidemiology
• Investigators: Study Chair: Muwei Li, MD, FF

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2021
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: HenanICE202102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Others can obtain the individual participant data from the researcher by reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No