Suspended

FORZAFFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

What is being tested

FFR guided PCI

+ OCT guided PCI

Device

Who is being recruted

Amino Acid Metabolism, Inborn Errors+15

+ Brain Diseases

+ Brain Diseases, Metabolic

Over 18 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: April 2013

See protocol details

Summary

Principal SponsorCatholic University of the Sacred Heart

Study ContactFrancesco Burzotta, MD, PhDMore contacts

Last updated: April 9, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01824030

Principal SponsorCatholic University of the Sacred Heart

Study ContactFrancesco Burzotta, MD, PhDMore contacts

Last updated: April 9, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Amino Acid Metabolism, Inborn ErrorsBrain DiseasesBrain Diseases, MetabolicCardiovascular DiseasesCentral Nervous System DiseasesHeart DiseasesMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNutritional and Metabolic DiseasesVascular DiseasesBrain Diseases, Metabolic, InbornGenetic Diseases, InbornGenetic Diseases, X-LinkedUrea Cycle Disorders, InbornMyocardial IschemiaOrnithine Carbamoyltransferase Deficiency Disease

Criteria

3 inclusion criteria required to participate

multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis

multivessel disease with multiple intermediate coronary artery stenosis only

single vessel disease with an intermediate coronary artery stenosis

16 exclusion criteria prevent from participating

advance renal failure with glomerular filtration rate < 30 ml/min

age < 18 years or impossibility to give informed consent

female sex with child-bearing potential

gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Rome, ItalyOpen Policlinico A. Gemelli. Università Cattolica del Sacro Cuore in Google Maps

SuspendedOne Study Center