NCT01158053

Vascular Evaluation for Revascularization: Defining the Indications for Coronary Therapy: A Pilot Study

A Prospective, Global, Multicenter, Non-Randomized, Non-Blinded Study in Patients With Intermediate Coronary Lesions to Examine the Correlation Between Fractional Flow Reserve (FFR) and Intravascular Ultrasound With Virtual Histology (VH-IVUS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 291 (actual)
• Sponsor: Volcano Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present prospective, multicenter study will therefore be performed with the primary objective of establishing the correlation between fractional flow reserve (FFR) and intravascular ultrasound with virtual histology (VH-IVUS)-derived parameters in angiographically intermediate coronary lesions. The current study will also examine the relative prognostic utility of FFR and VH-IVUS as a tool to defer percutaneous coronary intervention (PCI), by assessing the long-term rate (up to 3 years) of lesion-related clinical events if deferred by FFR vs. VH-IVUS versus not deferred PCI.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	FFR and VH-IVUS	* Stable Angina(SA), Unstable Angina(UA),Non ST-segment Elevation Myocardial Infarction(NSTEMI) or ST-segment Elevation Myocardial Infarction(STEMI) \>48hrs scheduled for cardiac catheterization ± PCI. All patient level inclusion and no exclusion criteria are met Signed Informed Consent * No PCI or successful and uncomplicated PCI of all non study lesions. One or more study lesions identified. All lesion level inclusion criteria and no exclusion criteria are met. * FFR followed by VH-IVUS of study lesion(s) * Any additional PCI based on routine clinical practice and FFR/IVUS data? * If Yes: Final IVUS with VH imaging, Clinical follow-up at hospital discharge, 30 days, 6 months, and then yearly for 3 years * If No: Clinical follow-up at hospital discharge, 30 days, 6 months, and then yearly for 3 years
DEVICE	IVUS and FFR

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-04-01
• Completion: 2015-01-01
• First posted: 2010-07-08
• Last updated: 2015-12-10