Fluid-dynamics in Bifurcation PCI

NCT ID: NCT03174418

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2021-03-31

Brief 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.

Conditions

Atherosclerosis, Coronary

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A

Patients with bifurcated coronary lesions treated by percutaneous coronary interventions.

Coronary angiography and optical coherence tomography

Intervention Type: PROCEDURE

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

Cohort B

Patients with untreated bifurcated coronary lesions.

Coronary angiography and optical coherence tomography

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Francesco Burzotta

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Burzotta, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Locations

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Roma, , Italy

Countries

Italy

Central Contacts

Francesco Burzotta, MD

Role: CONTACT

francesco.burzotta@unicatt.it

+39 3494295290

Facility Contacts

Francesco Burzotta, MD, PhD

Role: primary

francesco.burzotta@unicatt.it

+39 349-429-5290

Other Identifiers

01012017

Identifier Type: -

Identifier Source: org_study_id