Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03824626
Other study ID # 160/int/2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2019
Est. completion date January 30, 2022

Study information

Verified date October 2020
Source Ospedale San Donato
Contact Massimiliano M Marrocco-Trischitta, MD,PhD
Phone +393332084440
Email massimiliano.marroccotrischitta@grupposandonato.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thoracic endovascular aortic repair (TEVAR) for disease involving the aortic arch remains complex and challenging due the angulation and tortuosity of the arch and its peculiar biomechanical environment. Currently, TEVAR planning is based on the analysis of anatomical features by means of static imaging protocols. Such an approach, however, disregards the impact of pulsatile forces that are transmitted as migration forces on the terminal fixation sites of the endograft, and may jeopardize the long-term clinical success of the procedure. Hence,the investigators aim to assess the migration forces acting on different proximal landing zones of the aortic arch by computational modeling, and develop in silico patient-specific simulations that can provide a quantitative evaluation of the stent-graft performance. Study's results are expected to provide valuable insights for proper proximal landing zone and stent-graft selection during TEVAR planning, and ultimately improve postoperative outcome.


Description:

Read more »
Read more »

Study Design


Intervention

Diagnostic Test:
TEVAR patients
Computed Tomography Angiography (CTA) will be performed using a 16-slice unit before and after intravenous administration of 100 mL of iodinated contrast material. Phase contrast-Magnetic Resonance (pc-MRI) will be performed using a 1.5-T unit with 40-mT/m gradient power and a four-channel cardio-thoracic coil. ECG-triggered, free-breathing through plane, and in-plane pc-MRI sequences will be performed for phase-velocity mapping of aortic and branches flow. Ad hoc processing of preoperative CTAs, based on 3D multiplanar reconstruction, will be performed with 3Mensio Vascular software 8.0® (3Mensio Medical Imaging B.V.), which provides specific functions for automatic measurements.

Locations

Country Name City State
Italy IRCCS Policlinico San Donato San Donato Milanese Milan

Sponsors (2)

Lead Sponsor Collaborator
Ospedale San Donato University of Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (15)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Displacement Force [magnitude (N)] Comparison among the Type of Arch (TOA); Comparison among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR) 18 months
Primary Displacement Force [Vector (-)] Comparison among the Type of Arch (TOA); Comparison among pre- and post-Thoracic Endovascular Aortic Repair (TEVAR) 18 months
Secondary Area of proximal landing zones (PLZs) (mm2) Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR 18 months
Secondary Equivalent Surface Traction (EST) (N/ mm2) Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR 18 months
Secondary Radius of curvature (1/mm) Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR 18 months
Secondary Angulation (tangent angle function) Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR 18 months
Secondary Tortuosity (tortuosity angle function) Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR 18 months
Secondary Mean and maximum flow velocity magnitude (cm/sec) in aortic along the cardiac cycle Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR 18 months
Secondary Systolic wall shear stress (dyn/cm2) Comparison among the TOA and PLZs 18 months
Secondary Time-averaged wall shear stress (TAWSS) (dyn/cm2) Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR 18 months
Secondary Oscillatory index (OSI) (%) Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR 18 months
Secondary Flow helicity Comparison among the TOA and PLZs; Comparison among pre- and post-TEVAR 18 months
Secondary Aortic inflow (L/min) Comparison among the TOA; Comparison among pre- and post-TEVAR 18 months
Secondary Aortic flow split (%) Comparison among the TOA; Comparison among pre- and post-TEVAR 18 months
Secondary Brachial arterial pressure (mmHg) Comparison among the TOA; Comparison among pre- and post-TEVAR 18 months
Secondary Mean and maximum arterial pressure (mmHg) Comparison among the TOA; Comparison among pre- and post-TEVAR 18 months
See also
  Status Clinical Trial Phase
Completed NCT05582967 - The DAShED (Diagnosis of Aortic Syndrome in the ED) Study
Terminated NCT04116684 - Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients N/A
Completed NCT02086136 - Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection
Recruiting NCT02201589 - Feasibility of Endovascular Repair Of Ascending Aortic Pathologies N/A
Recruiting NCT03948555 - Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation
Enrolling by invitation NCT05912608 - Optimal Strategy for Repair of Type A Acute Aortic Dissection
Recruiting NCT03707743 - Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)
Enrolling by invitation NCT00583817 - Endovascular Treatment of Thoracic Aortic Disease N/A
Recruiting NCT05073991 - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Not yet recruiting NCT02523300 - Glucocorticoid on the Prognosis of TEVAR N/A
Completed NCT01197651 - Aortic-Stent-Register N/A
Recruiting NCT04471909 - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness N/A
Not yet recruiting NCT06044259 - Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection N/A
Completed NCT05039814 - Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C
Recruiting NCT03780738 - A Validation Study of The Relationship Between ALDH2 and Aortic Dissection
Completed NCT03647566 - 18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
Enrolling by invitation NCT05800743 - Evaluation of the GORE® Ascending Stent Graft N/A
Recruiting NCT03347812 - Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair N/A
Completed NCT05044494 - Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection
Terminated NCT02958098 - My Research Legacy Pilot Study