Coronary Disease
Conditions
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.
Interventions
OTHERDrug eluting stent
Put a Drug eluting stent in the blood vessel
OTHERDurg coated balloon
Put a Durg coated balloon in the blood vessel
Sponsors
Henan Institute of Cardiovascular Epidemiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three different strategies for true bifurcation
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure rate | 30days | Cardiac death,Target vessel MI,Target lesion revascularization |
Countries
China
Outcome results
None listed