Randomised Control Trial of Vascular Access Site Closure with FemoSeal™ vs StarClose™ in patients undergoing angiography

Not Applicable

Withdrawn

• Conditions: Arteriotomy closure; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Surgery - Surgical techniques

• Registration Number: ACTRN12620000469910
• Lead Sponsor: orthern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Participants will be recruited from a population undergoing diagnostic and interventional peripheral vascular procedures. Participants undergoing arterial access via the common femoral artery (CFA) with a 6F or 7F sheath, on a single or dual antiplatelet treatment.

These participants will be identified pre operatively by study personnel. They will be invited by one of the researchers to participate in the trial. Patient Information Sheets and Consent Forms will be provided to prospective participants for review prior to obtaining consent. If they wish to participate, written informed consent will be obtained and the patient will be enrolled into the study. Participants will have time to consider and withdraw participation from the time they are informed and/or consented for the trial.
Inclusion criteria
•antegrade or retrograde CFA US guided puncture
•6F or 7F sheath size
•CFA diameter >5mm
•on an antiplatelet agent

Exclusion Criteria

1. acute limb ischaemia
2. prior open femoral intervention (ie femoral endarterectomy)
3. prior VCD use within 30 days
4. heavily calcified vessel not suitable for VCD
5. bleeding diathesis
6. hypertension with either SBP > 220 or DBP > 110
•pregnancy
•allergy to nitinol or bioabsorable polymer

Study & Design

• Study Type: Interventional
• Study Design: Not specified