"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions

NCT04753827 | Completed

• 1 other identifier: HenanICE202102
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (2)

• main vessel late lumen loss

  main vessel late lumen loss

  6 months

• Side branch late lumen loss

  Side branch late lumen loss

  6 months

Secondary Outcomes (2)

• Target lesion failure rate

  30days

• Target lesion failure rate

  6 months

Study Arms (3)

Experimental Group Stent only

EXPERIMENTAL

Stents were implanted in MV and SB respectively, and DKcrush or Culotte technology was selected according to the lesion characteristics.

Other: Drug eluting stent

Experimental Group Stent+DCB

EXPERIMENTAL

The MV was stented and the SB were treated with just drug-coated balloon(DCB)

Other: Drug eluting stent; Other: Durg coated balloon

Experimental Group L-Sandwich

EXPERIMENTAL

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; Other: Durg coated balloon

Interventions

Drug eluting stent OTHER

Put a Drug eluting stent in the blood vessel

Experimental Group L-Sandwich; Experimental Group Stent only; Experimental Group Stent+DCB

Durg coated balloon OTHER

Put a Durg coated balloon in the blood vessel

Experimental Group L-Sandwich; Experimental Group Stent+DCB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with true bifurcation disease with SB lesion length\>25mm

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Muwei Li, MD

  FF

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three different strategies for true bifurcation

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 15, 2021
• Study Start: October 3, 2021
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)