Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04753827
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2021-02-10
Brief Title:
L-Sandwich Strategy in the True Coronary Bifurcation Lesions
Sponsor:
Henan Institute of Cardiovascular Epidemiology
Organization:
Henan Institute of Cardiovascular Epidemiology
Study Overview
Official Title:
L-Sandwich Strategy in the True Coronary Bifurcation Lesions
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
L-Sandwich
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 vesselMV and the shaft of side branchSB respectively then a drug-coated balloonDCB 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 diseaseAll eligible patients were randomly divided into three groups experimental group 1 dual stent group both main vesselMV and side branchSB were stented and DK-Crush or Culotte were performed according to different pathological characteristics Experimental group 2 single stent drug-coated balloonDCB stent was implanted in the MV and only drug balloon was used in the SBExperimental group 3 L-Sandwich stent was implanted in the MV and the branch was implanted 3-5mm away from the ostiumand the DCB was implanted in the ostium of the branchIVUS angiography was used to guide the operation and evaluate the outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None