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

NCT01158053 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 291

Last updated 2015-12-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Volcano Corporation

    lead INDUSTRY

Principal Investigators

  • Gregg W Stone, MD · Columbia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-04-30
Completion
2015-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01158053 on ClinicalTrials.gov