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

Primary Purpose

Ischemic Heart Disease

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
FFR guided PCI
OCT guided PCI
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring FFR, OCT, Seattle Angina Questionnaire

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Policlinico A. Gemelli. Università Cattolica del Sacro CuoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

FFR guided PCI arm

OCT guided PCI arm

Arm Description

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

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

Outcomes

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*
*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

Full Information

First Posted
March 28, 2013
Last Updated
April 8, 2013
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01824030
Brief Title
FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty
Acronym
FORZA
Official Title
FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
FFR, OCT, Seattle Angina Questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFR guided PCI arm
Arm Type
Active Comparator
Arm Description
Patients with angiographic intermediate coronary artery stenosis randomized to FFR assessment. PCI performed only if FFR ≤ 0.80
Arm Title
OCT guided PCI arm
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
FFR guided PCI
Intervention Description
FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
Intervention Type
Device
Intervention Name(s)
OCT guided PCI
Intervention Description
OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Occurrence of angina defined as Seattle Angina Questionnaire score < 90 in angina frequency scale, at 13 month follow up from index procedure*
Description
*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"
Time Frame
13 months
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Periprocedural costs
Time Frame
30 days
Title
Periprocedural costs
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Burzotta, MD, PhD
Phone
+39 3494295290
Email
f.burzotta@rm.unicatt.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Burzotta, MD, PhD
Organizational Affiliation
Università Cattolica del Sacro Cuore, Roma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Burzotta, MD, PhD
Phone
349-429-5290
Ext
+39
Email
f.burzotta@rm.unicatt.it
First Name & Middle Initial & Last Name & Degree
Francesco Burzotta, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31918942
Citation
Burzotta F, Leone AM, Aurigemma C, Zambrano A, Zimbardo G, Arioti M, Vergallo R, De Maria GL, Cerracchio E, Romagnoli E, Trani C, Crea F. Fractional Flow Reserve or Optical Coherence Tomography to Guide Management of Angiographically Intermediate Coronary Stenosis: A Single-Center Trial. JACC Cardiovasc Interv. 2020 Jan 13;13(1):49-58. doi: 10.1016/j.jcin.2019.09.034.
Results Reference
derived
PubMed Identifier
31331219
Citation
Leone AM, Burzotta F, Aurigemma C, De Maria GL, Zambrano A, Zimbardo G, Arioti M, Cerracchio E, Vergallo R, Trani C, Crea F. Prospective Randomized Comparison of Fractional Flow Reserve Versus Optical Coherence Tomography to Guide Revascularization of Intermediate Coronary Stenoses: One-Month Results. J Am Heart Assoc. 2019 Aug 6;8(15):e012772. doi: 10.1161/JAHA.119.012772. Epub 2019 Jul 23.
Results Reference
derived
PubMed Identifier
24758510
Citation
Burzotta F, Leone AM, De Maria GL, Niccoli G, Coluccia V, Pirozzolo G, Saffioti S, Aurigemma C, Trani C, Crea F. Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial. Trials. 2014 Apr 23;15:140. doi: 10.1186/1745-6215-15-140.
Results Reference
derived

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FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

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