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NCT04111770: OPTIMAL
The OPTIMAL Randomized Controlled Trial
NA trial testing IVUS guided Percutaneous Coronary Intervention in Left Main Coronary Artery Stenosis in 806 participants. Completed in 31 July 2025.
31 July 2025
Quick facts
| Lead sponsor | ECRI bv |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 806 |
| Start date | 8 July 2020 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 July 2025 |
| Sites | 28 locations across Italy, United Kingdom, Spain |
Drugs / interventions tested
- IVUS guided Percutaneous Coronary Intervention
- Qualitative or quantitative angiography will guide percutaneous coronary intervention
Conditions studied
- Left Main Coronary Artery Stenosis — all drugs for Left Main Coronary Artery Stenosis →
Sponsor
ECRI bv — full company profile →
Who can join
18 and older, any sex, with Left Main Coronary Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The OPTIMAL study is a randomized, controlled, multicentre, international study. A total of 800 patients will be randomized in a 1:1 fashion to Intravascular Ultrasound (IVUS)-guided PCI versus qualitative angio(QCA)-guided Percutaneous Coronary Intervention (PCI). Patients will be consented prior to the PCI procedure and then followed up to 2 years after the index procedure for the last enrolled patient. Patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and yearly after (outpatient clinic visit or telephone call).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Percutaneous Coronary Intervention for Left Main Coronary Artery Disease: Present Status and Future Perspectives.
Park S, Park SJ, Park DW. · · 2022 · cited 29× · PMID 36339118 · DOI 10.1016/j.jacasi.2021.12.011 -
Intravascular Imaging-Guided Versus Angiography-Guided Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Trials.
Sreenivasan J, Reddy RK, Jamil Y, Malik A, et al · · 2024 · cited 27× · PMID 38214263 · DOI 10.1161/jaha.123.031111 -
A multi-center, international, randomized, 2-year, parallel-group study to assess the superiority of IVUS-guided PCI versus qualitative angio-guided PCI in unprotected left main coronary artery (ULMCA) disease: Study protocol for OPTIMAL trial.
De Maria GL, Testa L, de la Torre Hernandez JM, Terentes-Printzios D, et al · · 2022 · cited 14× · PMID 34995276 · DOI 10.1371/journal.pone.0260770 -
Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting for Revascularization of Left Main Coronary Artery Disease.
Park S, Park SJ, Park DW. · · 2023 · cited 6× · PMID 36914602 · DOI 10.4070/kcj.2022.0333 -
IVUS-Guided versus Angiography-Guided PCI in Unprotected Left Main Coronary Disease.
Testa L, De la Torre Hernandez JM, De Maria GL, Jones DA, et al · · 2026 · cited 1× · PMID 41911017 · DOI 10.1056/nejmoa2600440 -
Intravascular Imaging Guidance for Percutaneous Coronary Interventions.
Spagnolo M, Giacoppo D, Greco A, Capodanno D. · · 2025 · cited 1× · PMID 41303031 · DOI 10.3390/jcm14227994 -
Intravascular Imaging-Guided Percutaneous Coronary Intervention: Transforming Precision and Outcomes in Contemporary Practice.
Alqawasmi M, Blankenship JC. · · 2025 · PMID 41464785 · DOI 10.3390/jcm14248883 -
Quantitative Coronary Angiography Guidance for Drug-Eluting Stent Implantation: A Narrative Review.
Lee CW, Lee PH, Lee SW, Serruys PW. · · 2024 · PMID 39691560 · DOI 10.1002/hsr2.70286
Verify or expand the search:
- PubMed search for NCT04111770
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Left Main Coronary Artery Stenosis
Currently open trials in the same condition.
- NCT05650411 — Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs · NA · recruiting
- NCT03767621 — Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospecti · active not recruiting
Other ECRI bv trials
Trials by the same sponsor.
- NCT07276282 — Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction · Phase 3 · recruiting
- NCT04854070 — Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures · NA · active not recruiting
- NCT03851263 — Multislice Computed Tomography Assessment of PCSK9 Inhibition on Coronary Perfusion · Phase 4 · withdrawn
- NCT03851276 — A Multicentre, Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revasculariz · Phase 4 · withdrawn
- NCT03508219 — POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI) · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04111770 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ECRI bv
- Last refreshed: 6 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04111770.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing