Clinical trial NCT04753827: "L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
Official title: "L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three different strategies for true bifurcation
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: main vessel late lumen loss
timeFrame: 6 months
measure: Side branch late lumen loss
timeFrame: 6 months
Secondary outcomes:
measure: Target lesion failure rate
timeFrame: 30days
measure: Target lesion failure rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai central China cardiovascular Hospital
state: Henan
Study officials:
affiliation: FF
name: Muwei Li, MD
role: STUDY_CHAIR
References: