Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®

NCT04564560 | Completed

• 1 other identifier: 137828
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.

Conditions

Aorta Aneurysm

Keywords

Stents; Thrombosis

Outcome Measures

Primary Outcomes (3)

• Percentage of patients who have got treated post-surgery due to thrombosis or occlusion of stent graft leg

  Any endovascular or surgical procedure to treat thrombosis or occlusion

  12-36 months

• Percentage of patients who got an amputation post-surgery due to thrombosis or occlusion of stent graft leg

  Any amputation in the affected limb / same side as thrombosed stent graft leg

  12-36 months

• Percentage of patients who died post-surgery

  Death of any cause during the observation time

  12-36 months

Study Arms (1)

Patients treated with Zenith Alpha Spiral-Z®

Patients that from January 2017 until December 2019 received endovascular aortic repair with the Zenith Alpha Spiral-Z® at St. Olavs Hospital

Procedure: Endovascular aortic repair with Zenith Alpha Spiral-Z®

Interventions

Endovascular aortic repair with Zenith Alpha Spiral-Z® PROCEDURE

The Zenith Alpha Spiral-Z® stent graft may have an increased risk of thrombosis. The intervention in this study is to assess the extent and degree of thrombosis in patients treated with the Zenith Alpha Spiral-Z® during endovascular repair of aortic aneurysm

Patients treated with Zenith Alpha Spiral-Z®

Eligibility Criteria

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

Study Population

All patient treated at St. Olavs Hospital in the period January 2017 until December 2019 with endovascular aortic repair using the Zenith Alpha Spiral-Z® .

You may qualify if:

• Patients that have received endovascular treatment with the Zenith Alpha Spiral-Z® for an aortic aneurysm
• The endovascular procedure was performed at St Olavs Hospital from January 2017 until December 2019

You may not qualify if:

• None

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine

Trondheim, Norway

Location

MeSH Terms

Conditions

Aortic Aneurysm; Thrombosis

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Morten Troøyen, md

  St Olavs Hospital, Dept Radiology and Nuclear Medicine

  STUDY DIRECTOR

• Birger H Endreseth, md

  St Olavs Hospital, Dept Surgery

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 25, 2020
• Study Start: September 22, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

NO (1)