Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO)

NCT03484013 | Completed

• 1 other identifier: PEVAR-PRO/141/OSR
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the study is the evaluation of the applicability of the percutaneous technique through double Proglide and Pre-Close Technique to the treatment of complex aortic aneurysms with thoracic endoprosthesis (TEVAR), fenestrated or branched (F / B-EVAR) in which patient-related factors, the devices used or the procedure, could affect the performance.

Conditions

Aneurysm; Aneurysm Abdominal; Aneurysm Thoracic; Aneurysm, Thoracoabdominal Aortic

Outcome Measures

Primary Outcomes (1)

• technical success

  Use of femoral artery access in endovascular repair of aortic aneurysm (time frame between 2015 and 2020) * Endovascular procedure: TEVAR - EVAR - B/FEVAR * Side of femoral access: right- left * Employment of downsizing on the femoral access: yes - no, as reported on patients' charts and operative report * Size of percutaneous access sheath employed measured in French - Fr * Number of percutaneous access vessel closure devices employed * Access closure specific outcome: success - failure, as reported on patients' charts and operative report * Cause of failure: hemorrhagic - occlusive, as reported on patients' charts and operative report

  during the surgery

Secondary Outcomes (1)

• minor complications

  30 days after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

a sample of 320 subjects will be analyzed (considering the cases treated in the period: October 2015 - 31 december 2019). The analysis of the retrospective data, will be based on the consultation of the archive of the individual treated patients, present on software platform belonging to the San Raffaele Hospital Information System) as well as the medical records. An informatic database will be set up for the exclusive use of investigators. The data will be analyzed subsequently through the application of descriptive and inferential statistics techniques.

You may qualify if:

• adult patients aged ≥ 18 years, belonging to the Operative Unit of Vascular Surgery of the San Raffaele Hospital,
• patients candidates for endovascular treatment for thoracic, thoracoabdominal or abdominal aortic pathologies.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (1)

• Melloni A, Grandi A, Spelta S, Salvati S, Loschi D, Lembo R, Melissano G, Chiesa R, Bertoglio L. Outcomes of routine use of percutaneous access with large-bore introducer sheaths (>21F outer diameter) during endovascular aneurysm repair. J Vasc Surg. 2021 Jan;73(1):81-91. doi: 10.1016/j.jvs.2020.04.504. Epub 2020 May 19.

  PMID: 32442603 DERIVED

MeSH Terms

Conditions

Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: March 30, 2018
• Study Start: January 9, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 14, 2020

Record last verified: 2020-05

Locations

IT (1)