Trial · NCT03507777
ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
NCT03507777, Not applicable, Completed, Abbott Medical Devices; results first posted 2024-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI). Trials, record NCT03507777. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03507777
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
- NCT number
- NCT03507777
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,487 participants, actual
- Lead sponsor
- Abbott Medical Devices
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, STEMI, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
- Interventions
- Coronary PCI guided by OCT, Coronary PCI guided by Angiography
- First posted
- 2018-04-25
- Last updated
- 2024-08-01
- Results first posted
- 2024-08-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Imaging Outcome (Powered): Minimal Stent Area (MSA) | Final Post-PCI Measurement (average of 24 hours). | Minimal Stent Area (per target lesion basis) assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment. |
| Primary | Number of Participants With Target Vessel Failure (TVF) | At 2 years | Time-to-first event rate of the composite outcome of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR), will be assessed. |
| Secondary | Number of Participants With Target Vessel Failure (TVF) Excluding Periprocedural MI (Powered) | At 2 years | Time-to-first event rate of composite outcome of cardiac death, target vessel-related spontaneous myocardial infarction, or ischemia-driven target vessel revascularization (ID-TVR) will be assessed. |
| Secondary | The Results of Adjudicated Clinical Outcomes to 2 Years in the Randomized Population | 2 years | The results of adjudicated clinical outcomes to 2 years in the randomized population by Kaplan-Meier assessment. |
| Secondary | The Number of Participants With Stent Thrombosis | 2 years | The results of adjudicated clinical outcomes to 2 years in the randomized population by Kaplan-Meier assessment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Imaging Outcome (Powered): Minimal Stent Area (MSA) | Final Post-PCI Measurement (average of 24 hours). | The number of participants analyzed includes subjects who were available at that time of analysis | mm^2 | MEAN |
| PRIMARY | Number of Participants With Target Vessel Failure (TVF) | At 2 years | The number of participants analyzed includes subjects who were available at that time of analysis | participants who experienced the event | NUMBER |
| SECONDARY | Number of Participants With Target Vessel Failure (TVF) Excluding Periprocedural MI (Powered) | At 2 years | The number of participants analyzed includes subjects who were available at that time of analysis | participants who experienced the event | NUMBER |
| SECONDARY | The Results of Adjudicated Clinical Outcomes to 2 Years in the Randomized Population | 2 years | The number of participants analyzed includes subjects who were available at that time of analysis | participants | NUMBER |
| SECONDARY | The Number of Participants With Stent Thrombosis | 2 years | The number of participants analyzed includes subjects who were available at that time of analysis | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Imaging Outcome (Powered): Minimal Stent Area (MSA) | Coronary PCI Guided by OCT | 5.72 | Standard Deviation 2.04 | mm^2 | |
| Imaging Outcome (Powered): Minimal Stent Area (MSA) | Coronary PCI Guided by Angiography | 5.36 | Standard Deviation 1.87 | mm^2 | |
| Number of Participants With Target Vessel Failure (TVF) | Coronary PCI Guided by OCT | 88 | participants who experienced the event | ||
| Number of Participants With Target Vessel Failure (TVF) | Coronary PCI Guided by Angiography | 99 | participants who experienced the event | ||
| Number of Participants With Target Vessel Failure (TVF) Excluding Periprocedural MI (Powered) | Coronary PCI Guided by OCT | 74 | participants who experienced the event | ||
| Number of Participants With Target Vessel Failure (TVF) Excluding Periprocedural MI (Powered) | Coronary PCI Guided by Angiography | 82 | participants who experienced the event | ||
| The Results of Adjudicated Clinical Outcomes to 2 Years in the Randomized Population | Coronary PCI Guided by OCT | All Death | 32 | participants | |
| The Results of Adjudicated Clinical Outcomes to 2 Years in the Randomized Population | Coronary PCI Guided by Angiography | All Death | 44 | participants | |
| The Results of Adjudicated Clinical Outcomes to 2 Years in the Randomized Population | Coronary PCI Guided by OCT | All MI | 57 | participants | |
| The Results of Adjudicated Clinical Outcomes to 2 Years in the Randomized Population | Coronary PCI Guided by Angiography | All MI | 72 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Coronary PCI Guided by OCT | 1,233 | |
| Overall Study | STARTED | Coronary PCI Guided by Angiography | 1,254 | |
| Overall Study | COMPLETED | Coronary PCI Guided by OCT | 1,189 | |
| Overall Study | COMPLETED | Coronary PCI Guided by Angiography | 1,184 | |
| Overall Study | NOT COMPLETED | Coronary PCI Guided by OCT | 44 | |
| Overall Study | NOT COMPLETED | Coronary PCI Guided by Angiography | 70 |
Source ClinicalTrials.gov
Adverse events736
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | CARDIAC ENZYMES INCREASED | Investigations | Coronary PCI Guided by OCT | 71 | 1,233 | |
| other | CARDIAC ENZYMES INCREASED | Investigations | Coronary PCI Guided by Angiography | 73 | 1,254 | |
| serious | ANAEMIA | Blood and lymphatic system disorders | Coronary PCI Guided by OCT | 12 | 1,233 | |
| serious | ANAEMIA | Blood and lymphatic system disorders | Coronary PCI Guided by Angiography | 6 | 1,254 | |
| serious | HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | Coronary PCI Guided by OCT | 1 | 1,233 | |
| serious | HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | Coronary PCI Guided by Angiography | 0 | 1,254 | |
| serious | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Coronary PCI Guided by OCT | 3 | 1,233 | |
| serious | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Coronary PCI Guided by Angiography | 0 | 1,254 | |
| serious | ACUTE CORONARY SYNDROME | Cardiac disorders | Coronary PCI Guided by OCT | 1 | 1,233 | |
| serious | ACUTE CORONARY SYNDROME | Cardiac disorders | Coronary PCI Guided by Angiography | 0 | 1,254 |
1 to 10 of 736Source ClinicalTrials.gov
See all 736 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Coronary PCI Guided by OCT | 33 | 1,233 |
| Total, all-cause mortality | Coronary PCI Guided by Angiography | 44 | 1,254 |
| Total, other adverse events | Coronary PCI Guided by OCT | 71 | 1,233 |
| Total, other adverse events | Coronary PCI Guided by Angiography | 73 | 1,254 |
| Total, serious adverse events | Coronary PCI Guided by OCT | 405 | 1,233 |
| Total, serious adverse events | Coronary PCI Guided by Angiography | 411 | 1,254 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Coronary PCI Guided by OCT vs Coronary PCI Guided by Angiography: deaths from any cause | Trial comparisons |
| Coronary PCI Guided by OCT vs Coronary PCI Guided by Angiography: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03507777
GET https://conductscience.org/api/trials/v1/NCT03507777/results?page=2