NCT05611190

CT-FFR-guided Strategy for In-stent Restenosis

Coronary CT Angiography-Derived Fractional Flow Reserve-guided Optimize Treatment Strategy for In-stent Restenosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: Yan'an Affiliated Hospital of Kunming Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a prospective, randomized clinical trial to compare standard practice guided by usual care testing to CT-FFR-guided management in patients with in-stent restenosis.

Detailed description

This trial will randomize 294 patients with in-stent restenosis to receive either CT-FFR or routine clinical assessment. In all subjects, the investigators will review all diagnostic test results and determine a treatment strategy. The primary end point will be 12-month Major Adverse Coronary Event (MACE) rates, defined as all cause death, non-fatal myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR). Secondary end points will include total medical costs, and quality of life (QOL), medical radiation exposure, etc. We will test noninferiority of current FFR-guided strategy compared with standard care strategy.

Conditions

• Coronary Artery Disease
• In-stent Restenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT-FFR	CT-FFR is a type of non-invasive procedure to provide a 3D model of coronary arteries as a way to evaluate the hemodynamic significance of coronary artery lesions. CT-FFR calculates FFR from subject-specific CCTA data using computational fluid dynamics technology. CT-FFR value ≤0.80 is considered hemodynamically significant.
DIAGNOSTIC_TEST	Usual Care	Participants randomized to usual care will be evaluated according to institutional standard practice.

Timeline

• Start date: 2022-12-12
• Primary completion: 2024-12-11
• Completion: 2025-12-11
• First posted: 2022-11-09
• Last updated: 2022-11-09