None listed
Conditions
Brief summary
Closure of percutaneous access sites is a crucial part of modern day diagnostic and interventional angiography. Failure to achieve closure of arterial puncture sites can lead to multiple complications including haematomas, pseudoaneurysms, AV fistulas and retroperitoneal haemorrhages, some of which can be life-threatening. While it is currently used in Australia, FemoSeal is a relatively new technology. As such, there is a paucity of quality research comparing this device with other, more established devices in a variety of clinical settings. The proposed RCT will compare the procedural efficiency and clinical outcomes between Starclose and FemoSeal. This study aims to assess arterial access-related complications at 25 - 35 days after randomisation, along with the efficacy, safety and efficiency of the vascular closure devices in participants who have undergone diagnostic and/or interventional angiography. The hypothesis to be tested is that FemoSeal is not inferior to Starclose for access site-related complications.
Interventions
Randomised control trial comparing the efficacy and safety of two vascular closure devices in participants requiring vascular access site closure.
For patients undergoing angiographic procedures via the access to the common femoral artery with a 6 or 7Fr sheath who are deemed suitable anatomically for a vascular closure device (VCD) will be randomised into 2 arms - the control arm using a StarcloseTM device or a FemosealTM device. The will be conducted at the completion of the angiographic or in
Randomised control trial comparing the efficacy and safety of two vascular closure devices in participants requiring vascular access site closure. For patients undergoing angiographic procedures via the access to the common femoral artery with a 6 or 7Fr sheath who are deemed suitable anatomically for a vascular closure device (VCD) will be randomised into 2 arms - the control arm using a StarcloseTM device or a FemosealTM device. The will be conducted at the completion of the angiographic or interventional procedure on a single occasion. The StarcloseTM device is an extravascular, nitinol clip with provides mechanical closure of the arteriotomy in comparison the FemosealTM device which is made of a bio-absorbable polymer with both intra-luminal and extravascular components. The VCD will be deployed by or under the supervision of a consultant vascular surgeon, radiologist or cardiologist with formal training in angiography and dedicated accreditation to utilise either device. Deployment of VCDs (both StarcloseTM and FemosealTM) typically takes between 1-3mins by an experienced operator. The procedure will be conducted in a dedicated angiography suite in public and private hospitals.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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
Outcome results
None listed