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Conventional Versus Intentional StraTegy in Lesions With High Risk PrEdiction of Side Branch OccLusion in InterVEntion

NCT02644434 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2019-01-11

No results posted yet for this study

Summary

The purpose of the present study is to investigate if intentional strategy (a more aggressive side branch protection strategy: elective two-stent or jailed balloon technique) is associated with significant reduction of side branch occlusion rate compared to conventional strategy (provisional two-stent strategy or jailed wire technique) in patients at high risk of side branch occlusion (V-RESOLVE score≥12).

Conditions

Interventions

PROCEDURE

Conventional Strategy

Jailed wire technique: Both MV and SB are wired. The MV is stented with wire protection in SB. The SB is not further treated unless there is threatened SB closure, severe ostial pinching of SB (\>90%), TIMI flow grade decrease in SB, or SB dissection greater than type A. If one of these criteria exists, the SB would be rewired and a kissing balloon inflation is undertaken. Provisional two-stent strategy: Lesion preparation and MV stenting are the same as the jailed wire technique. Provisional T stenting of the SB could be undertaken if one of the following criteria exists after SB rewiring and a kissing balloon inflation is undertaken: threatened SB closure, severe ostial pinching of SB (\>90%), TIMI flow grade decrease in SB, or SB dissection greater than type A.

PROCEDURE

Intentional strategy

Jailed balloon technique: The technique has been detailed in previous studies. A monorail balloon that is angiographically sized to approximate the Side Branch (SB) vessel diameter is advanced into the SB. If there is TIMI flow grade decrease in the SB after MV stenting, the SB balloon is inflated to simulate attempt to reopen the SB. The procedure would be completed with the standard kissing balloon technique no matter there is SB compromise or not. Elective two-stent strategy: Patients in this subgroup would undergo crush procedure or any other elective two-stent strategy which stenting SB before MV stenting.

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Principal Investigators

  • Kefei Dou, MD, PhD · Fuwai Hospital and National Center for Cardiovascular Diseases

  • Bo Xu, MBBS · Fuwai Hospital and National Center for Cardiovascular Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2019-12-01
Completion
2020-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644434 on ClinicalTrials.gov