Trial Outcomes & Findings for Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair (NCT NCT01005212)

NCT ID: NCT01005212

Last Updated: 2024-04-12

Results Overview

Persistent of a pulsatile intrasac color flow outside the stent-graft

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: Same day outcome
• Results posted on: 2024-04-12

Participant Flow

Participant milestones

Measure	Single Arm study recruitment ended
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair

Baseline characteristics by cohort

Measure	Single Arm n=20 Participants AAA patients
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Same day outcome

Persistent of a pulsatile intrasac color flow outside the stent-graft

Outcome measures

Measure	Single Arm n=20 Participants Patients undergoig post-EVAR follow-up with CEUS
Endoleak Detection	9 Participants

Adverse Events

CEUS-Single Arm

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

Bevin Lopez, Clinical Trials Manager

Houston Methodist Research Institute - Heart Center Research

Phone: 7134413912

Email: balopez@houstonmethodist.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place