Fluid-dynamics in Bifurcation PCI
FORECAST
A Multicentre Prospective Study on the Role of Fluid Dynamics OCT-based REconstruction of Coronary Atherosclerosis in bifurcationS to Predict ouTcome
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2017
CompletedFirst Posted
Study publicly available on registry
June 2, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJune 2, 2017
May 1, 2017
1 year
May 30, 2017
May 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Target vessel failure
1,6,12,18,24 and 36 months
Bifurcated lesion angiographic failure
1,6,12,18,24 and 36 months
Study Arms (2)
Cohort A
Patients with bifurcated coronary lesions treated by percutaneous coronary interventions.
Cohort B
Patients with untreated bifurcated coronary lesions.
Interventions
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
Eligibility Criteria
Patients with stable or unstable coronary artery disease due to atherosclerosis involving a major bifurcation site, who undergo diagnostic or interventional invasive percutaneous coronary procedures with the use of optical coherence tomography (OCT) based on operator's choice.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Roma, 00168, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Burzotta, MD
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 30, 2017
First Posted
June 2, 2017
Study Start
September 1, 2017
Primary Completion
September 1, 2018
Study Completion
March 1, 2021
Last Updated
June 2, 2017
Record last verified: 2017-05