Fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair

Randomized two-centre trial to investigate whether the fascia suture technique (FST) can reduce access closure time and procedural costs in comparison to the Prostar technique (Prostar) in patients undergoing endovascular aortic repair and to evaluate the short- and mid-term outcome of both techniques

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68739781

Enrollment

100

Registered

2014-01-27

Start date

2006-06-07

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving surgical performance Surgery

Interventions

Participants are randomised to one of the following two groups: 1. Intervention group: patients having a fascia suture for access closure 2. Control group: patients having the Prostar access closure

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All patients planned for abdominal endovascular aortic repair (EVAR) or thoracic endovascular aortic repair (TEVAR) for aneurysm or dissection 2. Planned femoral access 3. Planned for at least 16 F outer diameter of introducer or stent graft system on the main access site

Exclusion criteria

Exclusion criteria: 1. Aorto-uni-iliac stentgrafts with femoro-femoral bypass 2. Femoral aneurysm 3. Ruptured aneurysms 4. Emergency operations without preoperative ultrasound 5. Ongoing anticoagulation treatment with warfarin

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 18/06/2014: Time for access closure, measured with a stopwatch during the primary procedure Previous primary outcome measures: 1. Time for access closure, measured with a stopwatch during the primary procedure 2. Cost for access closure, measured at the primary procedure and at reported adverse event leading to an additional procedure and/or hospital stay during the 6-month follow-up period by calculation of material cost (disposables), cost for operative procedure (minutes), ICU stay (hours) and hospital stay (days)	—

Measure

Time frame

Current primary outcome measures as of 18/06/2014: Time for access closure, measured with a stopwatch during the primary procedure Previous primary outcome measures: 1. Time for access closure, measured with a stopwatch during the primary procedure 2. Cost for access closure, measured at the primary procedure and at reported adverse event leading to an additional procedure and/or hospital stay during the 6-month follow-up period by calculation of material cost (disposables), cost for operative procedure (minutes), ICU stay (hours) and hospital stay (days)

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Secondary

Measure	Time frame
Current secondary outcome measures as of 18/06/2014: Previous secondary outcome measures: 1. Technical success of access closure 2. Access-related complications 3. Cost for access closure, measured at the primary procedure and at reported adverse event leading to an additional procedure and/or hospital stay during the 6-month follow-up period by calculation of material cost (disposables), cost for operative procedure (minutes), ICU stay (hours) and hospital stay (days) Both outcomes will be measured at the operative procedure, at discharge, at 30 days and 6 months follow-up by doctor´s preference and ultrasound at 1 and 6 months. Previous secondary outcome measures: 1. Technical success of access closure 2. Access-related complications Both outcomes will be measured at the operative procedure, at discharge, at 30 days and 6 months follow-up by doctor´s preference and ultrasound at 1 and 6 months.	—

Measure

Time frame

Current secondary outcome measures as of 18/06/2014: Previous secondary outcome measures: 1. Technical success of access closure 2. Access-related complications 3. Cost for access closure, measured at the primary procedure and at reported adverse event leading to an additional procedure and/or hospital stay during the 6-month follow-up period by calculation of material cost (disposables), cost for operative procedure (minutes), ICU stay (hours) and hospital stay (days) Both outcomes will be measured at the operative procedure, at discharge, at 30 days and 6 months follow-up by doctor´s preference and ultrasound at 1 and 6 months. Previous secondary outcome measures: 1. Technical success of access closure 2. Access-related complications Both outcomes will be measured at the operative procedure, at discharge, at 30 days and 6 months follow-up by doctor´s preference and ultrasound at 1 and 6 months.

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Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026