NCT01824030

FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-04-04
• Last updated: 2013-04-09

Locations

1 site across 1 country: Italy