Vascular Evaluation for Revascularization: Defining the Indications for Coronary Therapy: A Pilot Study (VERDICT)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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)|
- 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 ] [ Designated as safety issue: No ]
- The concordance between operator assessed % diameter stenosis(DS), core lab assessed %DS, FFR and MLA in intermediate lesions [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- FFR and VH-IVUS derived MLA, %PB, lesion length, and plaque type in deferred vs. treated lesions [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
- Treated study lesion clinical event rates up to three years and their correlation with index FFR and VH-IVUS pre and post stenting [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Study Completion Date:||January 2015|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
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.
- 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
- Eagle Eye IVUS catheter
- Prine Wire
All lesion level inclusion criteria and no exclusion criteria are met.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158053
|Principal Investigator:||Gregg W Stone, MD||Columbia University|