Fluid-dynamics in Bifurcation PCI

Atherosclerosis, Coronary Clinical Trial

— FORECAST  

Official title:

A Multicentre Prospective Study on the Role of Fluid Dynamics OCT-based REconstruction of Coronary Atherosclerosis in bifurcationS to Predict ouTcome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03174418
• Other study ID #: 01012017
• Status: Not yet recruiting
• Phase: N/A
• First received: May 30, 2017
• Last updated: May 30, 2017
• Start date: September 2017
• Est. completion date: March 2021

Study information

• Verified date: May 2017
• Source: Catholic University of the Sacred Heart
• Contact: Francesco Burzotta, MD
• Phone: +39 3494295290
• Email: francesco.burzotta[@]unicatt.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigator-initiated, international, multicentre, observational study with two cohorts.

The two study cohorts will be:

Cohort A: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with bifurcated coronary lesions treated by PCI.

Cohort B: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with sub-critical bifurcated lesions managed conservatively.

Coronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the time-averaged WSS at the bifurcated lesion level by using computational fluid dynamics software.

Baseline (in patients both managed conservatively and treated by PCI) and post-PCI (in patients treated by PCI) images will be processed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2021
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Patients with stable or unstable coronary artery disease;

• TIMI 3 on both MV and SB;

• MV visual diameter > 2.5 mm;

• SB visual diameter > 2.0 mm;

• Documentation of angiographically-critical (visually estimated percentage diameter stenosis =80% <100%) coronary lesion treated by PCI and underwent post-PCI OCT assessment or angiographically-intermediate (visually estimated percentage diameter stenosis ranging between 30-80%) lesion in the MV considered suitable for conservative management (myocardial revascularization not planned).

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.).

• Ascertained or suspected contraindications to prolonged (up to 6 month) double antiplatelet therapy.

• Known hypersensitivity to aspirin, heparin, contrast dye, sirolimus, everolimus, zotarolimus, cobalt, chromium, nickel, tungsten acrylic, and fluoro-polymers.

• Poor cardiac function as defined by left ventricular global ejection fraction = 30%.

• Recent (< 48 hours) ST-segment elevation myocardial infarction.

• 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.

• Advance renal failure with glomerular filtration rate < 30 ml/min (Cockcroft-Gault equation)

• Left main lesion.

• Target bifurcation located on a distal coronary segment.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis, Coronary
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary angiography and optical coherence tomography
Coronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the arterial time-averaged wall shear stress at the bifurcated lesion level

Locations

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

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
Primary	Target bifurcation failure (TBF)	- Target bifurcated lesion-related major adverse coronary event (MACE) defined as the composite of: cardiac death; myocardial infarction (MI) not clearly related with another vessel; target vessel revascularization (TVR)	1,6,12,18,24 and 36 months
Secondary	Target vessel failure	- In the absence of target bifurcated lesion-related MACE, target bifurcated lesion angiographic failure defined, in patients treated by PCI, as: > 50% restenosis on the main vessel (MV) or TIMI (Thrombolysis In Myocardial Infarction) flow < 3 on the side branch (SB) at angiography eventually performed during the clinical course.	1,6,12,18,24 and 36 months
Secondary	Bifurcated lesion angiographic failure	Cardiac death; MI; TVR; Definite or probable stent thrombosis	1,6,12,18,24 and 36 months