Comparison · NCT03507777-sae
Coronary PCI Guided by OCT vs Coronary PCI Guided by Angiography: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Coronary PCI Guided by OCT vs Coronary PCI Guided by Angiography: serious adverse events. Trial comparisons, record NCT03507777-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03507777-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.328 | 0.303 | 0.355 | wilson | |
| Risk in group 2 | 0.328 | 0.302 | 0.354 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000716 | -0.0361 | 0.0376 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.896 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.849 | 1.19 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Coronary PCI Guided by OCT than on Coronary PCI Guided by Angiography | 1,400 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Coronary PCI Guided by OCT | Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation.~At the end of the procedure, a final OCT imaging run must be performed.~Coronary PCI guided by OCT: Stent implantation in high-risk or complex lesions in patients with coronary artery disease using OCT guidance | 405 | 1,233 | EG000 |
| Group 2 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES).~Stenting will be performed with angiography guidance according to local standard practice.~At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.~Coronary PCI guided by Angiography: Stent implantation in high-risk or complex lesions in patients with coronary artery disease using angiography guidance | 411 | 1,254 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 years
Source ClinicalTrials.gov
Trial
- Title
- ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
- NCT number
- NCT03507777
- Phases
- NA
- 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
- Lead sponsor
- Abbott Medical Devices
- Results first posted
- 2024-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03507777?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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