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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Francesco Burzotta, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01824030
First received: March 28, 2013
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Disease
Device: FFR guided PCI
Device: OCT guided PCI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    *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:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Periprocedural costs [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Periprocedural costs [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824030

Contacts
Contact: Francesco Burzotta, MD, PhD +39 3494295290 f.burzotta@rm.unicatt.it

Locations
Italy
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore Recruiting
Rome, Italy, 00168
Contact: Francesco Burzotta, MD, PhD    349-429-5290 ext +39    f.burzotta@rm.unicatt.it   
Principal Investigator: Francesco Burzotta, MD, PhD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Francesco Burzotta, MD, PhD Università Cattolica del Sacro Cuore, Roma
  More Information

No publications provided by Catholic University of the Sacred Heart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Burzotta, MD, PhD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01824030     History of Changes
Other Study ID Numbers: 6261/13
Study First Received: March 28, 2013
Last Updated: April 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
FFR, OCT, Seattle Angina Questionnaire

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Stenosis
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014