FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

Phase 3

• Conditions: Ischemic Heart Disease
• Interventions: Device: FFR guided PCI; Device: OCT guided PCI

• Registration Number: NCT01824030
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-28
• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-04
• Last Update Submitted: 2013-04-08
• Last Update Posted: 2013-04-09
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• multivessel disease requiring coronary aortic bypass graft intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FFR guided PCI arm	FFR guided PCI	Patients with angiographic intermediate coronary artery stenosis randomized to FFR assessment. PCI performed only if FFR ≤ 0.80
OCT guided PCI arm	OCT guided PCI	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

Primary Outcome Measures

Name	Time	Method
Occurrence of angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 month follow up from index procedure*	13 months	\*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"

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore; 🇮🇹 Rome, Italy