Trials / Completed
CompletedNCT03507777
ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,487 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Coronary Artery Disease
- Coronary Stenosis
- Atherosclerosis
- STEMI
- STEMI - ST Elevation Myocardial Infarction
- NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-05-17
- Primary completion
- 2023-02-28
- Completion
- 2023-02-28
- First posted
- 2018-04-25
- Last updated
- 2024-08-01
- Results posted
- 2024-08-01
Locations
90 sites across 20 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
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03507777. Inclusion in this directory is not an endorsement.