Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000784910
Ethics application status
Approved
Date submitted
8/06/2020
Date registered
3/08/2020
Date last updated
24/03/2022
Date data sharing statement initially provided
3/08/2020
Date results information initially provided
24/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of FemoStopTM II Gold compression system versus vascular closure devices (VCDs) on the total rate of groin puncture site complications (FemoClo Study)
Scientific title
Comparison of FemoStopTM II Gold compression system versus vascular closure devices (VCDs) on the total rate of groin puncture site complications in angioplasty patients (FemoClo Study)
Secondary ID [1] 301452 0
None
Universal Trial Number (UTN)
U1111-1253-1216
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral arterial disease 317762 0
Angioplasty 317763 0
Arteriotomy closure 317764 0
Peripheral Vascular Disease 318001 0
Condition category
Condition code
Surgery 315829 315829 0 0
Other surgery
Cardiovascular 316034 316034 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
FemoStop™ II Gold Compression System is a single use system which includes:
• Integrated manometer allows pressure to be adjusted based on patient status
• The inflatable, transparent dome offers precise pressure for effective haemostasis
• Adjustable belt designed to fit securely so small patient movements may not cause the device to slip
• Transparent dome ensures puncture site visibility
The FemoStop™ Gold Compression System will only be used for compression of the femoral artery after vessel cannulation by or on the order of physicians trained in femoral artery compression procedures.
For successful compression, the system must be correctly positioned throughout the procedure so that pressure is applied to the point intended. A disposable belt will be placed under the patient prior to the procedure and readjusted to precise placement on completion of the procedure. The target inflation pressure should be 10-20mmHg above the systolic pressure, or higher if necessary to control the bleeding. Exceeding pressures of 200mmHg may indicate the need to tighten the belt or reposition the dome. Application of FemoStop™ II Gold Compression System is as follows:
1. Pull the red tab to activate the pump
2. Position belt in line with puncture site(s), equal on both sides.
3. Peel back lid, keeping the dome sterile
4. Centre dome over arterial puncture (superior and medial to skin incision). Keep sheath hubs clear of dome rim.
5. Attach belt to arch and fit snug. Ensure arch is level and square across the groin area. Adjust by pulling on appropriate corner of belt to make arch perpendicular to femoral compression site.
6. Inflate dome to 20-30 mmHg
7. Further inflate to 60-80 mmHg and remove arterial sheath. Then quickly increase pressure in dome to be 10-20mmHg greater than systolic BP or higher as necessary to maintain initial haemostasis.
8. After 3 minutes maximum; lower to a maintenance pressure until limb profusion is restored to baseline and haemostasis is maintained. Check pedal pulse periodically to confirm whether or not flow remains in vessel. After appropriate duration as defined by hospital guidelines; lower by 10-20 mmHg every few minutes until you reach zero. Leave in place at low pressure if appropriate. Remove carefully. Dress wound. Discard device.
9. An additional bed rest for minimum of 3 hours.

Adherence to protocol of FemoStop application will be reported in the nursing notes.
Intervention code [1] 317761 0
Treatment: Devices
Comparator / control treatment
Group A receiving FemoStop™ II Gold Compression System for compression of the femoral artery will be compared to Group B vascular closure device.

Vascular devices (VCDs) are readily used at RPH include FemoSeal, Star Close, Angioseal and Mynx. All of the VCDs are applied by the interventionist according to the company's instructions for use under the guidance of DUS. VCD will be determined by clinician preference

Allocation to FemoStop or VCD will be determined by random allocation by computer generated number groups
Control group
Active

Outcomes
Primary outcome [1] 324034 0
Comparison of major and minor groin complications between two groups (patients receiving the FemoStopTM II Gold compression system versus patients receiving a vascular closure device). Groin complications will be assessed by physical examination at the following time points; immediately after application of a femoral artery closure procedure, prior to discharge from recovery to the ward, and before inpatient hospital stay discharge. The groin puncture site will be examined for - Oozing: presence of any leakage of blood from the puncture site. The blood tainted area is < 3 x 3cm2 on the gauze, but it does not reach the level of bleeding. - Ecchymosis (bruising): presence of any skin discolouration associated with pain and minor swelling. - Bleeding: considered present when there is more than 2g/dl loss from baseline of haemoglobin from puncture site. - Haematoma: swelling mass around the puncture site hard, palpable and tender. (Small haematoma: < 5cm in diameter; Large haematoma: > 5cm in diameter). - Pseudoaneurysm: pulsatile mass; presence of a palpable mass with corresponding movement to systole and diastole diagnosed by DUS detecting flow (if clinically indicated). - Retroperitoneal bleeding: moderate to severe back pain associated with hypotension and tachycardia diagnosed by computed tomography (CT) and DUS, if clinically indicated. - Femoral occlusion (thrombosis): complete occlusion of the femoral vessel as detected by the absence of distal foot pulses, and confirmed by DUS detecting flow, if clinically indicated. - Arteriovenous fistula: abnormal communication between the femoral artery and vein produces palpable thrill and bruit sound confirmed by a stethoscope placed over the puncture site, and by DUS detecting flow, if clinically indicated. Minor groin complications include oozing, ecchymosis and small haematoma (less than 5cm). Major complications include large haematoma (more than 5cm), bleeding, retroperitoneal bleeding and pseudoaneurysm
Timepoint [1] 324034 0
At three time points - immediately post-procedure for groin assessment (prior to the application of either device), during recovery (30-60 minutes), and at discharge
Secondary outcome [1] 383592 0
Comparison of major and minor groin complications between two groups (patients receiving the FemoStopTM II Gold compression system versus patients receiving a vascular closure device). Groin complications will be assessed by physical examination at 30-days post-procedure. The groin puncture site will be examined for - Oozing: presence of any leakage of blood from the puncture site. The blood tainted area is < 3 x 3cm2 on the gauze, but it does not reach the level of bleeding. - Ecchymosis (bruising): presence of any skin discolouration associated with pain and minor swelling. - Bleeding: considered present when there is more than 2g/dl loss from baseline of haemoglobin from puncture site. - Haematoma: swelling mass around the puncture site hard, palpable and tender. (Small haematoma: < 5cm in diameter; Large haematoma: > 5cm in diameter). - Pseudoaneurysm: pulsatile mass; presence of a palpable mass with corresponding movement to systole and diastole diagnosed by DUS detecting flow (if clinically indicated). - Retroperitoneal bleeding: moderate to severe back pain associated with hypotension and tachycardia diagnosed by computed tomography (CT) and DUS, if clinically indicated. - Femoral occlusion (thrombosis): complete occlusion of the femoral vessel as detected by the absence of distal foot pulses, and confirmed by DUS detecting flow, if clinically indicated. - Arteriovenous fistula: abnormal communication between the femoral artery and vein produces palpable thrill and bruit sound confirmed by a stethoscope placed over the puncture site, and by DUS detecting flow, if clinically indicated.
Timepoint [1] 383592 0
Assessed at a single time point 30-days post-procedure
Secondary outcome [2] 407887 0
To compare pain and discomfort after a femoral artery closure procedure between two groups (patients receiving the FemoStopTM II Gold compression system versus patients receiving a vascular closure device) immediately after application of a fermoral artery closure procedure; prior to discharge from recovery to the ward; before inpatient hospital stay discharge; and, 30 days post-procedure.
Timepoint [2] 407887 0
At four time points - immediately post-procedure for groin assessment (prior to the application of either device), during recovery (30-60 minutes), at discharge, 30-days post-index procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Statistical methods / analysis
An intention to treat analysis will be performed to accommodate for patients that are lost to follow-up, or lack of patient compliance. Statistical analysis will be performed using standard t-test, chi-square analysis, or Fischer exact test. Descriptive statistics will be presented for all primary and secondary endpoints. For quantitative variables, the mean values, standard deviation, maximum and minimum, as well as the 95% confidence interval (CI) for the mean will be calculated where relevant. For qualitative variables, absolute and relative frequencies are determined and the 95% CI for proportions are calculated where relevant. A Kaplan-Meier curve analysis looking at freedom from local groin complication will be conducted.

Anonymised data will be entered into an excel spreadsheet. The statistical package, STATA®, version 16.0 will be used for analysis. A p-value of <0.05 will be used for statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2020
Actual
7/12/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
17/11/2021
Date of last data collection
Anticipated
31/01/2021
Actual
30/12/2021
Sample size
Target
136
Accrual to date
Final
142
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16841 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 22015 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 30486 0
6000 - Perth
Recruitment postcode(s) [2] 37133 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 305886 0
Hospital
Name [1] 305886 0
Royal Perth Hospital Vascular Department
Country [1] 305886 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
180 Wellington Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 306341 0
None
Name [1] 306341 0
Address [1] 306341 0
Country [1] 306341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306147 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 306147 0
197 Wellington Street
Perth WA 6000
Ethics committee country [1] 306147 0
Australia
Date submitted for ethics approval [1] 306147 0
26/06/2020
Approval date [1] 306147 0
15/09/2020
Ethics approval number [1] 306147 0
Ethics committee name [2] 310628 0
Ramsay Health Care WA|SA HREC
Ethics committee address [2] 310628 0
Research and Ethics Office
c/o CGU Building
PO Box 242
Joondalup WA 6919
Ethics committee country [2] 310628 0
Australia
Date submitted for ethics approval [2] 310628 0
08/04/2021
Approval date [2] 310628 0
07/05/2021
Ethics approval number [2] 310628 0
2116W

Summary
Brief summary
Peripheral Vascular Disease (PVD) is a common condition often treated with angioplasty, a minimally invasive endovascular procedure to widen narrow or obstructed arteries or veins, typically used to treat atherosclerosis. Removal of the femoral sheath requires adequate compression which can be achieved by manual compression (MC) or with the use of vascular closure devices (VCD). The aim of this study is to evaluate the safety of the FemoStop™ II Gold compression system post-peripheral angioplasty in patients with PVD. The study will also aim to analyse rates of groin complication between the FemoStop™ II Gold compression system and VCD, allowing physicians to better decide which method has least post-operative complications and better patient satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65382 0
Ms Irina Shevchenko
Address 65382 0
Royal Perth Hospital
Department of Vascular Surgery
Main Operating Theatres, Level 4, North Block,
180 Wellington Street
Perth, WA, 6000
Country 65382 0
Australia
Phone 65382 0
+61 8 9224 2365
Fax 65382 0
Email 65382 0
[email protected]
Contact person for public queries
Name 65383 0
Ms Irina Shevchenko
Address 65383 0
Royal Perth Hospital
Department of Vascular Surgery
Main Operating Theatres, Level 4, North Block,
180 Wellington Street
Perth, WA, 6000
Country 65383 0
Australia
Phone 65383 0
+61 8 9224 2365
Fax 65383 0
Email 65383 0
[email protected]
Contact person for scientific queries
Name 65384 0
Ms Irina Shevchenko
Address 65384 0
Royal Perth Hospital
Department of Vascular Surgery
Main Operating Theatres, Level 4, North Block,
180 Wellington Street
Perth, WA, 6000
Country 65384 0
Australia
Phone 65384 0
+61 8 9224 2365
Fax 65384 0
Email 65384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual data in including demographic data, procedural information, complications and follow up data
When will data be available (start and end dates)?
Data will be available immediately following publication. There is no end date to availability. Data will be available for 5 years after publication and beyond
Available to whom?
only researchers who provide a methodologically sound proposal,
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator email [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.