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Whether to revascularize patients with angiographically-intermediate coronary lesions (AICL) is a major clinical issue. Intravascular techniques (assessing either the anatomy or the functional effect of coronary stenoses) are routinely used to better characterize coronary lesions. Among these,fractional flow reserve (FFR) provides validated functional insights while optical coherence tomography (OCT) provides high resolution anatomic imaging. Both techniques may be applied to guide decisions regarding the opportunity to revascularize patients with AICL and to optimize the result of percutaneous coronary intervention (PCI). We aim to compare the clinical and the economical impact of FFR versus OCT guidance in the percutaneous management of patients with AICL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR guided PCI arm | Active Comparator | Patients with angiographic intermediate coronary artery stenosis randomized to FFR assessment. PCI performed only if FFR ≤ 0.80 |
|
| OCT guided PCI arm | Active Comparator | Patients with angiographic intermediate coronary artery stenosis randomized to OCT. PCI will be performed if:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR guided PCI | Device | FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 month follow up from index procedure* | *In case of MACE rate absolute difference of >1% between the two study arms, the primary end-point will be: "Occurrence of Major Cardiovascular Event and angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 months follow up from index procedure" | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Major Cardiovascular Event and angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 months follow up from index procedure | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural costs | 30 days | |
| Periprocedural costs | 13 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Burzotta, MD, PhD | Contact | +39 3494295290 | f.burzotta@rm.unicatt.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Burzotta, MD, PhD | Università Cattolica del Sacro Cuore, Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico A. Gemelli. Università Cattolica del Sacro Cuore | Recruiting | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38660794 | Derived | Aurigemma C, Ding D, Tu S, Li C, Yu W, Li Y, Leone AM, Romagnoli E, Vergallo R, Maino A, Trani C, Wijns W, Burzotta F. Three-Year Clinical Impact of Murray Law-Based Quantitative Flow Ratio and OCT- or FFR-Guidance in Angiographically Intermediate Coronary Lesions. Circ Cardiovasc Interv. 2024 May;17(5):e013191. doi: 10.1161/CIRCINTERVENTIONS.123.013191. Epub 2024 Apr 25. | |
| 37172214 |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D020163 | Ornithine Carbamoyltransferase Deficiency Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D056806 | Urea Cycle Disorders, Inborn |
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| OCT guided PCI | Device | OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention |
|
| Derived |
| Ding D, Tu S, Li Y, Li C, Yu W, Liu X, Leone AM, Aurigemma C, Romagnoli E, Vergallo R, Trani C, Wijns W, Burzotta F. Quantitative flow ratio modulated by intracoronary optical coherence tomography for predicting physiological efficacy of percutaneous coronary intervention. Catheter Cardiovasc Interv. 2023 Jul;102(1):36-45. doi: 10.1002/ccd.30681. Epub 2023 May 12. |
| 31918942 | Derived | Burzotta F, Leone AM, Aurigemma C, Zambrano A, Zimbardo G, Arioti M, Vergallo R, De Maria GL, Cerracchio E, Romagnoli E, Trani C, Crea F. Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial. JACC Cardiovasc Interv. 2020 Jan 13;13(1):49-58. doi: 10.1016/j.jcin.2019.09.034. |
| 31331219 | Derived | Leone AM, Burzotta F, Aurigemma C, De Maria GL, Zambrano A, Zimbardo G, Arioti M, Cerracchio E, Vergallo R, Trani C, Crea F. Prospective Randomized Comparison of Fractional Flow Reserve Versus Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses: One-Month Results. J Am Heart Assoc. 2019 Aug 6;8(15):e012772. doi: 10.1161/JAHA.119.012772. Epub 2019 Jul 23. |
| 24758510 | Derived | Burzotta F, Leone AM, De Maria GL, Niccoli G, Coluccia V, Pirozzolo G, Saffioti S, Aurigemma C, Trani C, Crea F. Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial. Trials. 2014 Apr 23;15:140. doi: 10.1186/1745-6215-15-140. |
| D020739 |
| Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |