Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation

NCT04714268 | Unknown

• 1 other identifier: 002
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.

Conditions

Aortic Aneurysm; Iliac Aneurysm; Stenoses, Aortic; Iliac Artery Stenosis

Outcome Measures

Primary Outcomes (4)

• Volume of contrast product used during the routine care procedure (ml)

  Volume are reported in mL

  At enrollment

• Irradiation parameters: evaluation of the Fluoroscopy duration (min)

  Parameter given by the X-ray imaging device

  At enrollment

• Irradiation parameters: dose-area quantification (mGy/m2)

  Parameter given by the X-ray imaging device

  At enrollment

• Irradiation parameters: measurement of air Kerma (mGy)

  Parameter given by the X-ray imaging device

  At enrollment

Secondary Outcomes (1)

• Procedure time (min)

  At enrollment

Study Arms (2)

Procedures with EndoNaut

Endovascular interventions using the EndoNaut workstation. 3D image fusion is used for overlaying arterial information on top of fluoroscopic images

Procedure: Aorto-iliac endovascular procedure

Procedures without EndoNaut

Control group, endovascular interventions without 3D image fusion

Procedure: Aorto-iliac endovascular procedure

Interventions

Aorto-iliac endovascular procedure PROCEDURE

Percutaneous procedure with stent placement

Procedures with EndoNaut; Procedures without EndoNaut

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients with unilateral or bilateral common iliac aneurysm or stenosis, treated with endovascular technique

You may qualify if:

• Unilateral or bilateral aorto-iliac or iliac aneurysm/stenosis
• Suitable for endovascular repair
• Major patients
• Patients not opposed to their participation in the study

You may not qualify if:

• Patients requiring conventional surgical revascularization.

Sponsors & Collaborators

• Therenva: lead
• Rennes University Hospital: collaborator
• Douai hospital: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator
• University Hospital, Brest: collaborator
• Polyclinique Bordeaux Nord Aquitaine: collaborator

Study Sites (1)

CHU Rennes

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm; Iliac Aneurysm; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Florent Lalys, PhD

CONTACT

+33789833846; florent.lalys@therenva.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)