None listed
Conditions
Brief summary
The Boomerang Catalyst VI System is designed to help in controlling bleeding (gaining haemostasis) following an arterial puncture made for the purpose of completing a coronary angiogram or angioplasty (procedures done in the cardiac catheter laboratory to look for or treat narrowings in the coronary arteries). This puncture is usually made in the femoral artery in the groin. Often haemostasis is gained by manual compression (using the fingers or hand) and the literature reported average time for this technique will be compared the time it takes to gain haemostasis using the wire and collagen patch components of the device, as well as compression. There are several other closure devices used in New Zealand, and more than 50% of procedures would now have these used. The device is placed into the femoral artery in the catheter laboratory once the angiogram has been completed, followed by a minimum of one minute of manual compression. 100 consecutive patients at 5 sites (20 per site) will be enrolled. The time taken to control the bleeding, time till the participant can stand and walk around, and the time till they are fit for discharge will be recorded. Also adverse, serious adverse and device adverse events will be recorded. Participants will be seen prior to discharge and again at 30 days and at these time points ultrasound will be used to assess the position of the collagen patch to the puncture site.
Interventions
In the Catheterization lab, provided no bleeding around the introducer sheath is observed and appropriate sterile technique is used, the Boomerang Catalyst VI Wire will be inserted through the indwelling 6F or 7F introducer sheath at the puncture site according to the Instructions for Use. After temporary hemostasis is achieved, imaging of the vessel will be performed to confirm correct placement of the device disc immediately prior to deployment of the extravascular collagen patch; the puncture
In the Catheterization lab, provided no bleeding around the introducer sheath is observed and appropriate sterile technique is used, the Boomerang Catalyst VI Wire will be inserted through the indwelling 6F or 7F introducer sheath at the puncture site according to the Instructions for Use. After temporary hemostasis is achieved, imaging of the vessel will be performed to confirm correct placement of the device disc immediately prior to deployment of the extravascular collagen patch; the puncture site will then be observed for oozing blood and or signs of hematoma formation. At some point after hemostasis and prior to discharge, another ultrasound of the vessel will be performed and a digital image recorded as a baseline for the appearance of the collagen patch in proximity to the arteriotomy site.
Sponsors
Cardiva Medical Inc
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
clinically scheduled for angiogram or angioplasty, able to ambulate >20 feet,
Exclusion criteria
current infection, femoral arteriotomy in <30 days, femoral arrter closure device in past 180 days, low platelets, high international normalised ratio (INR), anaemia, intra-procedural bleeding, high activated clotting time (ACT), A suspected intraluminal thrombus, hematoma, pseudo-aneurysm, or AV fistula of the target artery or 'multiple wall' arterial puncture.
Outcome results
None listed