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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

March 28, 2013
April 8, 2013
April 2013
April 2016   (final data collection date for primary outcome measure)
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"
Same as current
Complete list of historical versions of study NCT01824030 on ClinicalTrials.gov Archive Site
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 ]
Same as current
  • Periprocedural costs [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Periprocedural costs [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Same as current
 
FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty
FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Heart Disease
  • Device: FFR guided PCI
    FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
  • Device: OCT guided PCI
    OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
  • Active Comparator: FFR guided PCI arm
    Patients with angiographic intermediate coronary artery stenosis randomized to FFR assessment. PCI performed only if FFR ≤ 0.80
    Intervention: Device: FFR guided PCI
  • 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
    Intervention: Device: OCT guided PCI
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Francesco Burzotta, MD, PhD +39 3494295290 f.burzotta@rm.unicatt.it
Italy
 
NCT01824030
6261/13
Not Provided
Francesco Burzotta, Catholic University of the Sacred Heart
Catholic University of the Sacred Heart
Not Provided
Principal Investigator: Francesco Burzotta, MD, PhD Università Cattolica del Sacro Cuore, Roma
Catholic University of the Sacred Heart
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP