L-Sandwich Strategy in the True Coronary Bifurcation Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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L-Sandwich Strategy in the True Coronary Bifurcation Lesions

Conditions
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Coronary Disease

Intervention / Treatment
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* Other: Drug eluting stent
* Other: Durg coated balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three different strategies for true bifurcation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group Stent only<br>Stents were implanted in MV and SB respectively, and DKcrush or Culotte technology was selected according to the lesion characteristics. | Other: Drug eluting stent<br>* Put a Drug eluting stent in the blood vessel<br>|
| Experimental: Experimental Group Stent+DCB<br>The MV was stented and the SB were treated with just drug-coated balloon(DCB) | Other: Drug eluting stent<br>* Put a Drug eluting stent in the blood vessel<br>Other: Durg coated balloon<br>* Put a Durg coated balloon in the blood vessel<br>|
| Experimental: Experimental Group L-Sandwich<br>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<br>* Put a Drug eluting stent in the blood vessel<br>Other: Durg coated balloon<br>* Put a Durg coated balloon in the blood vessel<br>|

What is the study measuring?
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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 |