NCT05503407

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,104 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A number of 1104 patients scheduled for elective percutaneous coronary intervention (PCI) with native coronary bifurcation lesions suitable for stent implantation are included in the present study. This study will be conducted in two stages with 552 patients each. In the first stage, all patients receive angiography-guided PCI. In the second stage, all patients receive PCI under the guidance of baseline V-RESOLVE score.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2022-08-16
• Last updated: 2023-06-13

Locations

1 site across 1 country: China