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

Henan Institute of Cardiovascular Epidemiology

Status: Completed

Conditions: Coronary Disease

Treatments: Other: Durg coated balloon; Other: Drug eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT04753827

HenanICE202102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 3 patient groups

Experimental Group Stent only

Experimental group

Description:

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

Treatment:

Other: Drug eluting stent

Experimental Group Stent+DCB

Experimental group

Description:

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

Treatment:

Other: Drug eluting stent

Other: Durg coated balloon

Experimental Group L-Sandwich

Experimental group

Description:

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

Treatment:

Other: Drug eluting stent

Other: Durg coated balloon