FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

NCT01824030 | Unknown Phase 3

• 1 other identifier: 6261/13
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Heart Disease

Keywords

FFR, OCT, Seattle Angina Questionnaire

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Other Outcomes (2)

• Periprocedural costs

  30 days

• Periprocedural costs

  13 months

Study Arms (2)

FFR guided PCI arm

ACTIVE COMPARATOR

Patients with angiographic intermediate coronary artery stenosis randomized to FFR assessment. PCI performed only if FFR ≤ 0.80

Device: FFR guided PCI

OCT guided PCI arm

ACTIVE COMPARATOR

Patients with angiographic intermediate coronary artery stenosis randomized to OCT. PCI will be performed if: 1. percentage area stenosis ≥75 % 2. percentage area stenosis between 50 and 75% and minimal lumen area \<2.5 mm2 3. percentage area stenosis between 50 and 75% and major plaque ulceration

Device: OCT guided PCI

Interventions

FFR guided PCI DEVICE

FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention

FFR guided PCI arm

OCT guided PCI DEVICE

OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention

OCT guided PCI arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• single vessel disease with an intermediate coronary artery stenosis
• multivessel disease with multiple intermediate coronary artery stenosis only
• multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis

You may not qualify if:

• age \<18 years or impossibility to give informed consent,
• female sex with child-bearing potential,
• life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc),
• poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%
• recent (\< 7 days) ST-segment elevation myocardial infarction
• recent (\< 48 hours) Non ST-segment elevation myocardial infarction
• prior ST-segment elevation myocardial infarction in the territory supplied by the vessel with the intermediate stenosis under investigation
• severe myocardial hypertrophy (interventricular septum thickness \> 15 mm, ECG Sokolow's criteria fulfilled)
• severe valvular heart disease
• significant platelet count alteration (\<100,000 cells/mm3 or \> 700,000 cells/mm3)
• gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks
• history of clotting pathology
• known hypersensitivity to aspirin, heparin, contrast dye
• advance renal failure with glomerular filtration rate \< 30 ml/min
• lesions in coronary artery bypass grafts

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Rome, 00168, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 38660794 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.

  PMID: 37172214 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.

  PMID: 31918942 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.

  PMID: 31331219 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.

  PMID: 24758510 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Ornithine Carbamoyltransferase Deficiency Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Francesco Burzotta, MD, PhD

  Università Cattolica del Sacro Cuore, Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Burzotta, MD, PhD

CONTACT

+39 3494295290; f.burzotta@rm.unicatt.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

IT (1)