FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FFR guided PCI arm

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

Group Type ACTIVE_COMPARATOR

FFR guided PCI

Intervention Type DEVICE

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

OCT guided PCI arm

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

Group Type ACTIVE_COMPARATOR

OCT guided PCI

Intervention Type DEVICE

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

Interventions

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FFR guided PCI

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

Intervention Type DEVICE

OCT guided PCI

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No