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Trial registered on ANZCTR


Registration number
ACTRN12620000469910
Ethics application status
Approved
Date submitted
12/03/2020
Date registered
14/04/2020
Date last updated
14/04/2020
Date data sharing statement initially provided
14/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Control Trial of Vascular Access Site Closure with FemoSeal™ vs StarClose™ in patients undergoing angiography
Scientific title
Randomised Control Trial of Vascular Access Site Closure with FemoSeal™ vs StarClose™ - clinical outcomes and imaging features for patients undergoing angiography
Secondary ID [1] 300837 0
Nil known
Universal Trial Number (UTN)
U1111-1249-7065
Trial acronym
Study of Endovascular Arteriotomy CLosure (SEAL)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arteriotomy closure 316651 0
Condition category
Condition code
Cardiovascular 314895 314895 0 0
Diseases of the vasculature and circulation including the lymphatic system
Surgery 314969 314969 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317111 0
Treatment: Devices
Comparator / control treatment
Randomised control trial comparing the efficacy and safety of two vascular closure devices in participants requiring vascular access site closure.
Arm 1: FemoSeal device closure
Arm 2: StarClose device closure (control arm)
Control group
Active

Outcomes
Primary outcome [1] 323216 0
To assess arterial access­ related complications at 25 - 35 days post procedure as part of standard follow up assessment.
• Haematoma - palpable mass >3cm on clinical examination or ultrasound
• Pseudoaneurysm - as demonstrated on US duplex
• AV fistula - arterialised venous flow on duplex
• Bleeding – decrease in serum haemoglobin requiring transfusion
• Ipsilateral limb ischemia - acute limb ischaemia grade 1, 2a, 2b or 3 or duplex evidence of vessel occlusion
• Pain - pain reported to be between 1 and 10 on the verbal numerical rating scale at time of follow-up
• Local infection – requiring antibiotic/surgical treatment within 30 days of operation
Timepoint [1] 323216 0
25 - 35 days post procedure
Primary outcome [2] 323350 0
Percentage of successful deployment of the VCD - as assessed by clinical examination by the surgeon or operator of the groin site puncture. This would be accurately assessed using an electronic timer.
Timepoint [2] 323350 0
Haemostasis acheived within 2mins of deployment of the device.
Secondary outcome [1] 381201 0
3.2 Secondary Outcome(s)
• To determine time to haemostasis after sheath removal.
o Note, inadequate haemostasis may be defined as: haemostasis not achieved in 2 mins, thus necessitating manual compression.
Timepoint [1] 381201 0
This would be assessed by clinical assessment of the groin puncture site. Accurate timing would be ensured with utilization of an electronic timer.
Secondary outcome [2] 381625 0
To record any failures of the closure device to either deploy or achieve adequate haemostasis
Timepoint [2] 381625 0
Failure to acheive haemostasis within 2mins of deployment of the VCD. This would be assessed by clinical assessment of the groin puncture site. Accurate timing would be ensured with utilization of an electronic timer.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study investigators will register the patient in an online database (REDCap Database Vanderbilt University) controlled by the study investigators. This provides central computer generated randomization patients randomly allocated to a treatment arm, This will be revealed prior to the vascular closure device deployment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The data will be collated and analysed using data analysis software including SPSS. Continuous variables will be summarised with means and standard deviations, whilst categorical data will be summarised with counts and percentages. Both intention to treat and per protocol analysis will be used in the statistical analysis.
The sample size was determined using a power calculator employing the standard formula for a binary outcome, non-inferiority trial. The values used are as follows:
Significance level (alpha) = 5%
Power (1 – beta) = 90%
Percentage success in control group (i.e. StarClose arm) = 82%
Percentage success in experimental group (i.e. FemoSeal arm) = 89%
Non-inferiority limit (d) = 5%
The formula gives us a sample size of 147 per group, and a total sample size of 294.
The sample size is rounded up to 300 to account for screen failures, withdrawals or lost to follow-up.

The figures for ‘percentage success’ were selected based on results from key clinical trials in the literature, which closely resemble our own study design. The exact percentages were derived from reported rates of freedom from vascular access related complications at 30 days after successful device deployment. For StarClose we used data from a multicentre randomised control trial in the US comparing the StarClose device with manual compression. For FemoSeal data was used from a multicentre randomised control trial in Germany comparing FemoSeal, ExoSeal (an external vascular closure device), and manual compression.
The non-inferiority limit was set at 5% as this was deemed the largest difference that is clinically acceptable and remains less that the difference between success rates in the control and experimental groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16116 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 29635 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 305245 0
Hospital
Name [1] 305245 0
Royal North Shore Hospital
Address [1] 305245 0
Reserve Rd,
St Leonards
NSW 2065
Country [1] 305245 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Reserve Rd,
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 305602 0
None
Name [1] 305602 0
Address [1] 305602 0
Country [1] 305602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305588 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 305588 0
Reserve Rd,
St Leonards
NSW 2065
Ethics committee country [1] 305588 0
Australia
Date submitted for ethics approval [1] 305588 0
26/03/2018
Approval date [1] 305588 0
20/06/2018
Ethics approval number [1] 305588 0
2019/ETH08531

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100874 0
Dr Vikram Puttaswamy
Address 100874 0
Royal North Shore Hospital
(Dept of Vascular Surgery)
Reserve Rd
St Leonards
NSW
2065
Country 100874 0
Australia
Phone 100874 0
+61 2 94631767
Fax 100874 0
Email 100874 0
NSLHD-VascularSurgeryResearch@health.nsw.gov.au
Contact person for public queries
Name 100875 0
Ms Linda Pallot
Address 100875 0
Royal North Shore Hospital
(Dept of Vascular Surgery)
Reserve Rd
St Leonards
NSW
2065
Country 100875 0
Australia
Phone 100875 0
+61 2 94631767
Fax 100875 0
Email 100875 0
NSLHD-VascularSurgeryResearch@health.nsw.gov.au
Contact person for scientific queries
Name 100876 0
Dr Naomi Anning
Address 100876 0
Royal North Shore Hospital
(Dept of Vascular Surgery)
Reserve Rd
St Leonards
NSW
2065
Country 100876 0
Australia
Phone 100876 0
+61 2 94631767
Fax 100876 0
Email 100876 0
NSLHD-VascularSurgeryResearch@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study report will be provided at the conclusion of the study. Participant information will remain confidential.
What supporting documents are/will be available?
No other documents available
Summary results
No Results