Back to results"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions (L-Sandwich)
Primary Purpose
Coronary Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug eluting stent
Durg coated balloon
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Disease
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
Sites / Locations
- Fuwai central China cardiovascular Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Experimental Group Stent only
Experimental Group Stent+DCB
Experimental Group L-Sandwich
Arm Description
Stents were implanted in MV and SB respectively, and DKcrush or Culotte technology was selected according to the lesion characteristics.
The MV was stented and the SB were treated with just drug-coated balloon(DCB)
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
Outcomes
Primary Outcome Measures
main vessel late lumen loss
main vessel late lumen loss
Side branch late lumen loss
Side branch late lumen loss
Secondary Outcome Measures
Target lesion failure rate
Cardiac death,Target vessel MI,Target lesion revascularization
Target lesion failure rate
Cardiac death,Target vessel MI,Target lesion revascularization
Full Information
NCT ID
NCT04753827
First Posted
February 10, 2021
Last Updated
August 3, 2022
Sponsor
Henan Institute of Cardiovascular Epidemiology
1. Study Identification
Unique Protocol Identification Number
NCT04753827
Brief Title
"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
Acronym
L-Sandwich
Official Title
"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Institute of Cardiovascular Epidemiology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three different strategies for true bifurcation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group Stent only
Arm Type
Experimental
Arm Description
Stents were implanted in MV and SB respectively, and DKcrush or Culotte technology was selected according to the lesion characteristics.
Arm Title
Experimental Group Stent+DCB
Arm Type
Experimental
Arm Description
The MV was stented and the SB were treated with just drug-coated balloon(DCB)
Arm Title
Experimental Group L-Sandwich
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Drug eluting stent
Intervention Description
Put a Drug eluting stent in the blood vessel
Intervention Type
Other
Intervention Name(s)
Durg coated balloon
Intervention Description
Put a Durg coated balloon in the blood vessel
Primary Outcome Measure Information:
Title
main vessel late lumen loss
Description
main vessel late lumen loss
Time Frame
6 months
Title
Side branch late lumen loss
Description
Side branch late lumen loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Target lesion failure rate
Description
Cardiac death,Target vessel MI,Target lesion revascularization
Time Frame
30days
Title
Target lesion failure rate
Description
Cardiac death,Target vessel MI,Target lesion revascularization
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muwei Li, MD
Organizational Affiliation
FF
Official's Role
Study Chair
Facility Information:
Facility Name
Fuwai central China cardiovascular Hospital
City
Zhengzhou
State/Province
Henan
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Others can obtain the individual participant data from the researcher by reasonable request
Learn more about this trial
"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
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