None listed
Conditions
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.
Interventions
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
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.
Sponsors
Royal Perth Hospital
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 No maximum
Healthy volunteers
No
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.
Outcome results
None listed