Comparison of FemoStopTM II Gold compression system versus vascular closure devices (VCDs) on the total rate of groin puncture site complications (FemoClo Study)

Not Applicable

Completed

• Conditions: Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Peripheral arterial disease; Angioplasty; Arteriotomy closure; Peripheral Vascular Disease; Surgery - Other surgery

• Registration Number: ACTRN12620000784910
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-03
• Study Completion: 2021-12-30
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

•All participants male and non-pregnant female aged greater than or equal to 18 years of age
•Participant has provided written informed consent before any study specific test or procedure and is willing to comply with required follow-up
•Booked for elective/emergency endovascular procedure related to PVD pathology

Exclusion Criteria

•Participants unwilling to comply with study follow-up
•Females who are pregnant
•All patients who require a sheath to be upgraded above 7Fr
•All patients who receive thrombolysis treatment prior to the procedure
•All patients receiving continued heparin infusion
•Haemodynamically unstable patients with systolic blood pressure >200mmHg
•Patients who had endovascular treatment less than one month prior to current admission with the same femoral access site (to exclude possibility of existing groin complications)
•Patients with existing skin conditions in groin area including fungal infection; bruising and rashes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified