NCT03084367

Physiologic Assessment of Coronary Stenosis Following PCI

DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Volcano Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention).

Detailed description

DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR\<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.

Conditions

• Coronary Artery Disease
• Coronary Stenosis
• Angina, Unstable
• Angina, Stable

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	iFR pullback	iFR pullback assessment post angiographically successful PCI

Timeline

• Start date: 2017-06-20
• Primary completion: 2019-01-18
• Completion: 2020-02-18
• First posted: 2017-03-20
• Last updated: 2022-05-10
• Results posted: 2022-05-10

Locations

28 sites across 3 countries: United States, Netherlands, United Kingdom