ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"

NCT ID: NCT05309707

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2027-12-31

Brief Summary

The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

The secondary objective is to evaluate the safety and clinical performance of the studied devices.

Detailed Description

In this study patients will be observed, who receive a branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) for the endovascular treatment of aortic arch pathologies with proximal landing at zone 0. The devices will be implanted at the discretion of the treating physician.

Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the branch stent graft systems for aortic arch (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®). Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.

The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.

Conditions

Thoracic Aortic Aneurysm; Thoracic Aortic Dissection; Stent-Graft Endoleak; Stent-Graft Stenosis; Intramural Hematoma; Aortic Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with aortic arch pathologies treated by branch stent graft systems

Patients with aortic arch pathologies treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

Endovascular exclusion

Intervention Type: DEVICE

Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

Interventions

Endovascular exclusion

Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient is between 18 and 90 years old
• Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0.
• Patient must be available for the appropriate follow-up times for the duration of the study
• Informed consent signed.

Exclusion Criteria

• Patient less than 18 years old or more than 90 years old.
• Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium)
• Patient has systemic infection or suspected systemic infection
• Patient has thrombocytopenia (platelet count < 150000/µl)
• Patient has untreated hyperthyroidism
• Patient has a progressive or untreated malignancy.
• Patient is pregnant or breastfeeding.
• Patient has a life expectancy of less than 1 year.
• Not informed consent signed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Spanish society for Angiology and Vascular Surgery

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Enrique M San Norberto, MD, PhD, MsC, PGCert

Role: primary

esannorberto@hotmail.com

00346983420000 ext. 86962

Related Links

https://seacv.es

Spanish Society for Angiology and Vascular Surgery

Other Identifiers

2022-03

Identifier Type: -

Identifier Source: org_study_id