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Clinical Trial Summary

The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.


Clinical Trial Description

This is a prospective, single-blind clinical investigation randomizing subjects to OCT-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio. The clinical investigation will be conducted at approximately 125 centers in North America (US and Canada), Europe, Middle East and Asia-Pacific.

All patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.

After hospital discharge, all patients will have clinical follow-up at 30 days, 1 year, and 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03507777
Study type Interventional
Source St. Jude Medical
Contact Mariah Tackett
Phone +1 818-493-2385
Email mariah.tackett@abbott.com
Status Recruiting
Phase N/A
Start date March 26, 2018
Completion date July 31, 2022

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