Secondary Intervention and Surveillance After EVAR

• Sponsor: Hospital Sao Joao (Other)
• Overall Status: Completed
• CT.gov ID: NCT05335642
• Collaborator: (none)
• Enrollment: 214
• Location: 1
• Actual Duration (Months): 4
• Patients Per Site Per Month: 53.8

Study Details

Study Description

Brief Summary

This is a retrospective cohort study of consecutive patients submitted to elective EVAR, between February/2009 and May/2019 in a single institution. Symptomatic or ruptured AAA, mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were excluded. The primary outcomes were freedom from secondary intervention and compliance with follow-up, defined as surveillance imaging performed within a periodicity no longer than 18 months.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm Without Rupture	Procedure: EVAR

Study Design

• Study Type: Observational
• Actual Enrollment: 214 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Secondary Intervention and Surveillance After Abdominal Aortic Aneurysm Endovascular Repair: Retrospective Cohort Study
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Aug 31, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients that had secondary interventions after EVAR	Procedure: EVAR; Endovascular repair of abdominal aortic aneurysms
Patients without secondary interventions after EVAR	Procedure: EVAR; Endovascular repair of abdominal aortic aneurysms

Outcome Measures

Primary Outcome Measures

1. Number of participant with secondary intervention (SI) after EVAR [5 years follow up]

   SI included: access-related SI included suture of access bleeds, distal thrombo-embolectomy, patch angioplasty, or thromboendarterectomy of the common femoral artery; limb graft occlusion was defined as a thrombotic obstruction of blood flow in one or both endograft limbs, being a potential threat to the limb; lower limb ischemia was considered when there was a decrease in arterial perfusion of the limb, that was not related with limb graft occlusion; endoleak; stent migration was reported if no simultaneous type 1 endoleak was observed.

Secondary Outcome Measures

1. Number of participant with compliance with follow-up after EVAR [5 years follow up]

   Non-compliance with surveillance was defined by an 18 months period in which no surveillance imaging was performed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• This is a retrospective cohort study of consecutive patients submitted to elective EVAR, between February/2009 and May/2019 in a single institution.

Exclusion Criteria:

• Symptomatic or ruptured AAA, mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marina Felicidade Dias Neto	Porto	State/Province	Portugal	4200

Sponsors and Collaborators

• Hospital Sao Joao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marina Felicidade Dias Neto, Principal Investigator, Hospital Sao Joao
• ClinicalTrials.gov Identifier: NCT05335642
• Other Study ID Numbers: 10353
• First Posted: Apr 19, 2022
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Rupture

Study Results

No Results Posted as of Apr 19, 2022