FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

Ischemic Heart Disease Clinical Trial

— FORZA  

Official title:

FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01824030
• Other study ID #: 6261/13
• Status: Recruiting
• Phase: Phase 3
• First received: March 28, 2013
• Last updated: April 8, 2013
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2013
• Source: Catholic University of the Sacred Heart
• Contact: Francesco Burzotta, MD, PhD
• Phone: +39 3494295290
• Email: f.burzotta[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Stenosis
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• FFR guided PCI
FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
• OCT guided PCI
OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention

Locations

Country	Name	City	State
Italy	Policlinico A. Gemelli. Università Cattolica del Sacro Cuore	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Periprocedural costs		30 days	No
Other	Periprocedural costs		13 months	No
Primary	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"	13 months	No
Secondary	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	No