Status:
ACTIVE_NOT_RECRUITING
Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Acute Coronary Syndromes (ACS)
Chronic Coronary Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
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 (...
Detailed Description
The OCT-AGEM registry is an ambispective, single-center observational cohort study comprising a retrospective registry (Phase I) and a prospective registry (Phase II). All patients aged 18 years or ol...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Female with childbearing potential or lactating;
- Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl and/or glomerular filtration rate \<30 ml/min);
- Advanced heart failure (NYHA III-IV);
- Previous heart transplantation;
- Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
- Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
- 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;
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2036
Estimated Enrollment :
3200 Patients enrolled
Trial Details
Trial ID
NCT07182799
Start Date
September 1 2025
End Date
September 1 2036
Last Update
September 19 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Rome, Italy, 00168