Trial Outcomes & Findings for Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients (NCT NCT00583414)

Results Overview

Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

401 participants

Primary outcome timeframe

2 years

Results posted on

2019-01-25

Participant milestones
Measure	Endovascular Aneurysm Repair Investigational stent-graft implant to exclude aneurysm Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm
Overall Study STARTED	401
Overall Study COMPLETED	401
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Endovascular Aneurysm Repair n=401 Participants Investigational stent-graft implant to exclude aneurysm Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm
Age, Categorical <=18 years	0 Participants n=401 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=401 Participants
Age, Categorical >=65 years	345 Participants n=401 Participants
Sex: Female, Male Female	43 Participants n=401 Participants
Sex: Female, Male Male	358 Participants n=401 Participants
Presence of AAA or Iliac Aneurysm	401 participants n=401 Participants

Timeframe: 2 years

Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

Outcome measures
Measure	Endovascular Aneurysm Repair n=401 Participants Investigational stent-graft implant to exclude aneurysm Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm
Freedom From Aneurysm Rupture	0 Participants

Serious events: 9 serious events

Other events: 9 other events

Deaths: 292 deaths

Serious adverse events
Measure	Endovascular Aneurysm Repair n=401 participants at risk Investigational stent-graft implant to exclude aneurysm Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm
Vascular disorders Aneurysm Growth	2.2% 9/401 • At discharge, 1-, 6-, 12- and 24-month.

Other adverse events
Measure	Endovascular Aneurysm Repair n=401 participants at risk Investigational stent-graft implant to exclude aneurysm Endovascular Aneurysm Repair: Endovascular exclusion of aneurysm
Vascular disorders Aneurysm Growth	2.2% 9/401 • Number of events 9 • At discharge, 1-, 6-, 12- and 24-month.

Massachusetts General Hospital

Phone: 617-726-8279