CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,487 enrolled
Drug / intervention
Coronary PCI guided by OCT +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03507777
NCT03507777N/ACompleted
CompareCT.gov

OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI

Abbott Medical Devices·interventional·Posted Apr 25, 2018·Updated Aug 1, 2024

In Brief

A clinical study evaluating Coronary PCI guided by OCT and Coronary PCI guided by Angiography for Coronary Artery Disease and 5 related conditions. Completed, enrolled 2,487 participants across 90 sites in 20 countries.

Detailed Summary

The objective of this prospective, single-blind 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Coronary Stenosis, Atherosclerosis, STEMI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Netherlands, New Zealand, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
CollaboratorsAbbott

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 25, 2018
Enrollment StartMay 17, 2018
Primary CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.2 years ago

Interventions

Coronary PCI guided by OCTdevice

Stent implantation in high-risk or complex lesions in patients with coronary artery disease using OCT guidance

Coronary PCI guided by Angiographydevice

Stent implantation in high-risk or complex lesions in patients with coronary artery disease using angiography guidance