NCT07182799Active, not recruiting
Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance
Definition of Intra-procedural Optical Coherence Tomography (OCT) Clinical Impact, Both in Terms of Revascularization Indication and Procedural Result.
Source: ClinicalTrials.gov · Last updated 19 Sept 2025
Brief summary (registry, in English)
The starring optical coherence tomography during percutaneous coronary intervention guidance (OCT-AGEM) registry aims to evaluate the clinical impact of intra-procedural optical coherence tomography (OCT) in coronary revascularization, both in guiding revascularization decisions and optimizing interventional procedural outcomes, as well as assessing mid- and long-term clinical results.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 3200 (estimated)
- First submitted
- 2 Sept 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Sept 2031
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Coronary artery disease
- NCT number
- NCT07182799
What you commit to
- Study type: Observational
- Planned participants: 3200
- From 1 Sept 2025 to the primary completion date, 1 Sept 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous heart transplantation;
- Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
Other illness
- Advanced heart failure (NYHA III-IV);
Lab values
- Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl and/or glomerular filtration rate \<30 ml/min);
Other
- Female with childbearing potential or lactating;
- Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
- Heavily calcified lesion or tortuous vessel which cannot be successfully imaged by OCT;
- Lesion located at the coronary ostium or in angulated (\>70°), sharp take-off vessel;
Who the study is looking for
- Age over 18 years;
- Patients with clinical indication to coronary angiography undergoing intra-procedural OCT regardless of the clinical syndrome;
- Patients with at least one end-procedural OCT assessment with a sufficient acquisition length to address the whole length of plaque or stented segments plus the proximal and distal reference segments;
- Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.