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Baseline V-RESOLVE Score Guided Versus Angiography Guided Stent Implantation in Coronary Bifurcation Lesions (CIT-RESOLVE II)

NCT05503407 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1104

Last updated 2023-06-13

No results posted yet for this study

Summary

The purpose of this study is to investigate whether baseline V-RESOLVE score guided intervention is associated with significant reduction of side branch occlusion rates compared to angiography guided intervention in patients with coronary bifurcation lesions.

Conditions

Interventions

PROCEDURE

Baseline V-RESOLVE score-guided PCI

Jailed wire technique (JWT): Both main vessel (MV) and side branch (SB) are wired. The MV is stented with wire protection in SB. If suboptimal results exist, the SB would be rewired and a kissing balloon inflation (KBI) is undertaken. Jailed balloon technique: A monorail balloon 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. Provisional two-stent strategy: Lesion preparation and MV stenting are consistent with JWT. Provisional SB stenting could be undertaken when suboptimal results occur after SB rewiring and a KBI is undertaken. Elective two-stent strategy: Patients in this subgroup would undergo crush procedure or any other elective two-stent strategy which usually stenting SB before MV stenting.

PROCEDURE

Angiography-guided PCI

The choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram.

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2023-04-30
Completion
2023-04-30

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 NCT05503407 on ClinicalTrials.gov