FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty (FORZA)

April 8, 2013 updated by: Francesco Burzotta, Catholic University of the Sacred Heart
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: FFR guided PCI arm
Patients with angiographic intermediate coronary artery stenosis randomized to FFR assessment. PCI performed only if FFR ≤ 0.80
Device: FFR guided PCI
FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
ACTIVE_COMPARATOR: 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
Device: OCT guided PCI
OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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*
Time Frame: 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"
13 months

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 13 months
13 months

Other Outcome Measures

Outcome Measure
Time Frame
Periprocedural costs
Time Frame: 30 days
30 days
Periprocedural costs
Time Frame: 13 months
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Francesco Burzotta, MD, PhD, Università Cattolica del Sacro Cuore, Roma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

April 1, 2016

Study Completion (ANTICIPATED)

April 1, 2016

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (ESTIMATE)

April 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2013

Last Update Submitted That Met QC Criteria

April 8, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6261/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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