Fluid-dynamics in Bifurcation PCI

• Conditions: Atherosclerosis, Coronary
• Interventions: Procedure: Coronary angiography and optical coherence tomography

• Registration Number: NCT03174418
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-05-30
• Study First Posted: 2017-06-02
• Last Update Posted: 2017-06-02
• Study Start: 2017-09
• Primary Completion: 2018-09
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	Coronary angiography and optical coherence tomography	Patients with untreated bifurcated coronary lesions.
Cohort A	Coronary angiography and optical coherence tomography	Patients with bifurcated coronary lesions treated by percutaneous coronary interventions.

Primary Outcome Measures

Name	Time	Method
Target bifurcation failure (TBF)	1,6,12,18,24 and 36 months	- 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)

Secondary Outcome Measures

Name	Time	Method
Target vessel failure	1,6,12,18,24 and 36 months	- 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.
Bifurcated lesion angiographic failure	1,6,12,18,24 and 36 months	* Cardiac death; * MI; * TVR; * Definite or probable stent thrombosis

Trial Locations

Locations (1)

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore; 🇮🇹 Roma, Italy