NCT04854070

Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,020 (actual)
• Sponsor: ECRI bv · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The IVUS CHIP trial is a post-marketing strategy study in which patients with complex coronary lesions, undergoing percutaneous coronary intervention (PCI), are treated either with intravascular ultrasound (IVUS) guided PCI or angiographic guided PCI . The IVUS-guided PCI approach is indicated to reduce the frequency of target-lesion failure (cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization) in patients with complex coronary lesions undergoing PCI. The objective of this study is to assess the superiority of an IVUS-guided approach versus an angio-guided approach in patients with complex coronary lesions undergoing PCI.

Detailed description

During percutaneous coronary intervention (PCI) coronary arteries are visualized to guide placing the stent. In this study 2 currently utilized methods of visualizing coronary arteries during PCI are compared: intravascular ultrasound (IVUS) and angiographic guided PCI for patients with complex coronary lesions. The use of IVUS during PCI is suggested to give better results than angiographic guided PCI. The IVUS-CHIP trial is a randomized, controlled, multicenter, international, post-marketing study. A total of 2020 patients, in 7 European countries and approximately 40 hospitals, will be included, randomized in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI, and followed up for at least 2 years. The IVUS-CHIP is an event-driven study; primary analysis of the data will take place after at least 169 patients have experienced an event.

Conditions

• Complex Coronary Lesions

Interventions

Type	Name	Description
DEVICE	IVUS	IVUS-guided approach in patients with complex coronary lesions undergoing PCI
DEVICE	Angio	Angio-guided approach in patients with complex coronary lesions undergoing PCI

Timeline

• Start date: 2021-11-02
• Primary completion: 2024-07-17
• Completion: 2026-03-30
• First posted: 2021-04-22
• Last updated: 2026-03-04

Locations

37 sites across 7 countries: Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated device study