NCT03770650

IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions

Comparison of Intravascular Ultrasound-guided With Angiography-guided Double Kissing Crush Stenting Technique for Patients With Complex Coronary Bifurcation Lesions: The Prospective, Multi-center, Randomized DKCRUSH VIII Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 556 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate whether IVUS-guided DK crush stenting technique compared to angiography-guided DK crush after the indexed procedure will lead to lower rates of the composite endpoint of target vessel failure (TVF) at 12 months. The individual components of TVF include cardiac death, target-vessel myocardial infarction (MI), or target vessel revascularization (TVR). Complex bifurcation lesions were defined according to DEFINITION study.

Detailed description

This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 35 international sites. The investigators aim to enroll 556 subjects with complex coronary bifurcation lesions in native coronary arterial segments. All patients with complex coronary bifurcation lesions suitable for DES implantation will undergo 1:1 randomization either to IVUS-guided or angiography-guided DK crush stenting using a randomization schedule blocked by site. All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography before DES implantation. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven TVF, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Stenting	DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.

Timeline

• Start date: 2018-12-26
• Primary completion: 2025-09-30
• Completion: 2027-12-30
• First posted: 2018-12-10
• Last updated: 2026-04-13

Locations

1 site across 1 country: China