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ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)

NCT03507777 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2487

Last updated 2024-08-01

Study results available
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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.

Conditions

Interventions

DEVICE

Coronary PCI guided by OCT

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

DEVICE

Coronary PCI guided by Angiography

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

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Gregg W Stone, MD · Icahn School of Medicine at Mount Sinai

  • Ulf Landmesser, MD · Charite University, Berlin, Germany

  • Ziad A Ali, MD, DPhil · St Francis Hospital and Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2023-02-28
Completion
2023-02-28
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Portugal
  • Singapore
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03507777 on ClinicalTrials.gov