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)

Volcano Corporation0 sites291 target enrollmentSeptember 2010

ConditionsCoronary Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Volcano Corporation
Enrollment: 291
Primary Endpoint: The concordance between FFR and IVUS minimum lumen area(MLA) as assessed by continuous correlation (regression), categorical cutoff values , and being unadjusted and adjusted for lesion length, %plaque burden(PB) and VH-thin capped Fibro Atheroma(TCFA)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

January 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Volcano Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

The concordance between FFR and IVUS minimum lumen area(MLA) as assessed by continuous correlation (regression), categorical cutoff values , and being unadjusted and adjusted for lesion length, %plaque burden(PB) and VH-thin capped Fibro Atheroma(TCFA)

Time Frame: 3 year

Secondary Outcomes

The concordance between operator assessed % diameter stenosis(DS), core lab assessed %DS, FFR and MLA in intermediate lesions(3 year)
Operator assessed and core lab assessed angiographic %DS, and VH-IVUS MLA, lesion length, %PB, and plaque types in intermediate lesions, with core lab assessment as the reference(3 year)
FFR and VH-IVUS derived MLA, %PB, lesion length, and plaque type in deferred vs. treated lesions(3 year)
Operator revascularization decisions (deferral vs. PCI/coronary artery bypass graft(CABG)) according to operator assessed angiographic %DS, FFR and VH-IVUS results in intermediate coronary lesions(3 year)
Deferred study lesion clinical event rates up to three years according to %DS, FFR and VH-IVUS, and comparison with treated study lesion clinical event rates up to three years(3 year)
Treated study lesion clinical event rates up to three years and their correlation with index FFR and VH-IVUS pre and post stenting(3 year)