"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Group Stent only Stents were implanted in MV and SB respectively, and DKcrush or Culotte technology was selected according to the lesion characteristics. |
Other: Drug eluting stent
Put a Drug eluting stent in the blood vessel
|
| Experimental: Experimental Group Stent+DCB The MV was stented and the SB were treated with just drug-coated balloon(DCB) |
Other: Drug eluting stent
Put a Drug eluting stent in the blood vessel
Other: Durg coated balloon
Put a Durg coated balloon in the blood vessel
|
| Experimental: 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 |
Other: Drug eluting stent
Put a Drug eluting stent in the blood vessel
Other: Durg coated balloon
Put a Durg coated balloon in the blood vessel
|
Outcome Measures
Primary Outcome Measures
- main vessel late lumen loss [6 months]
main vessel late lumen loss
- Side branch late lumen loss [6 months]
Side branch late lumen loss
Secondary Outcome Measures
- Target lesion failure rate [30days]
Cardiac death,Target vessel MI,Target lesion revascularization
- Target lesion failure rate [6 months]
Cardiac death,Target vessel MI,Target lesion revascularization
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fuwai central China cardiovascular Hospital | Zhengzhou | Henan | China |
Sponsors and Collaborators
- Henan Institute of Cardiovascular Epidemiology
Investigators
- Study Chair: Muwei Li, MD, FF
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HenanICE202102