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FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

NCT01824030 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2013-04-09

No results posted yet for this study

Summary

Whether to revascularize patients with angiographically-intermediate coronary lesions (AICL) is a major clinical issue. Intravascular techniques (assessing either the anatomy or the functional effect of coronary stenoses) are routinely used to better characterize coronary lesions. Among these,fractional flow reserve (FFR) provides validated functional insights while optical coherence tomography (OCT) provides high resolution anatomic imaging. Both techniques may be applied to guide decisions regarding the opportunity to revascularize patients with AICL and to optimize the result of percutaneous coronary intervention (PCI). We aim to compare the clinical and the economical impact of FFR versus OCT guidance in the percutaneous management of patients with AICL.

Conditions

  • Ischemic Heart Disease

Interventions

DEVICE

FFR guided PCI

FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention

DEVICE

OCT guided PCI

OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Francesco Burzotta, MD, PhD · Università Cattolica del Sacro Cuore, Roma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Italy

Study Locations

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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 NCT01824030 on ClinicalTrials.gov