Trial Outcomes & Findings for AneuRx Post Market Study in the Treatment of AAA (NCT NCT00604552)

Results Overview

Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

349 participants

Primary outcome timeframe

5 year

Results posted on

2021-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Lifeline Registry All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)	PS Registry All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
Overall Study STARTED	189	160
Overall Study COMPLETED	189	160
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AneuRx Post Market Study in the Treatment of AAA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifeline Registry n=189 Participants All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)	PS Registry n=160 Participants All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic	Total n=349 Participants Total of all reporting groups
Age, Continuous	75.1 years STANDARD_DEVIATION 8.53 • n=5 Participants	74.3 years STANDARD_DEVIATION 7.31 • n=7 Participants	75.1 years STANDARD_DEVIATION 8.53 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	21 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	159 Participants n=5 Participants	139 Participants n=7 Participants	298 Participants n=5 Participants
Region of Enrollment United States	189 participants n=5 Participants	160 participants n=7 Participants	349 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 year

Population: All those treated on-label for the treatment of an AAA and followed out to 5 years.

Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion

Outcome measures

Outcome measures
Measure	Lifeline Registry n=189 Participants All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)	PS Registry n=160 Participants All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion Death	21 participants	20 participants
Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion Aneurysm Rupture	0 participants	1 participants
Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion Surgical Conversion	1 participants	2 participants

SECONDARY outcome

Timeframe: 5 years

Population: Study terminated before subjects met study 5 year endpoints. FDA agreed to closure of study prior to reaching the 5 year endpoint.

Outcome measures

Outcome data not reported

Adverse Events

Lifeline Registry

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PS Registry

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Angela Parsons

Medtronic Vascular

Phone: 707-591-2293

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place