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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03174418
Other study ID # 01012017
Secondary ID
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
Health authority
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.

Study Design


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
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