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

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01158053
• Lead Sponsor: Volcano Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Study Start: 2010-09
• Primary Completion: 2012-04
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	3 year

Secondary Outcome Measures

Name	Time	Method
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