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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-03

Study Completion Date

2022-07-20

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.

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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.

Conditions

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Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three different strategies for true bifurcation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group Stent only

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

Group Type EXPERIMENTAL

Drug eluting stent

Intervention Type OTHER

Put a Drug eluting stent in the blood vessel

Experimental Group Stent+DCB

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

Group Type EXPERIMENTAL

Drug eluting stent

Intervention Type OTHER

Put a Drug eluting stent in the blood vessel

Durg coated balloon

Intervention Type OTHER

Put a Durg coated balloon in the blood vessel

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

Group Type EXPERIMENTAL

Drug eluting stent

Intervention Type OTHER

Put a Drug eluting stent in the blood vessel

Durg coated balloon

Intervention Type OTHER

Put a Durg coated balloon in the blood vessel

Interventions

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Drug eluting stent

Put a Drug eluting stent in the blood vessel

Intervention Type OTHER

Durg coated balloon

Put a Durg coated balloon in the blood vessel

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No