Study of new femoral artery closure device to assist haemostasis in patients following cardiac catheterisation.
Not Applicable
Completed
- Conditions
- Coronary Heart DiseaseCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12609000588291
- Lead Sponsor
- Cardiva Medical Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary safety endpoint is the incidence of major adverse events of the image-guided investigational device did not exceed those of manual compression alone as reported in literature.[discharge and 30 days post procedure];The primary effectiveness endpoint is to demonstrate a superior (reduced) hold time till haemostasis with the Boomerang Catalyst VI System image-guided, extravascular patch as compared to literature controls for manual compression alone.[discharge and 30 days post procedure]
- Secondary Outcome Measures
Name Time Method the successful imaging of deployed Boomerang Catalyst VI disc and collagen patch prior to deployment, by clinician assessment[post procedure];device success rate, by clinician assessment and vascular ultrasound[post procedure];time to ambulation eligibility, by clinicain assessment[post procedure];time to discharge eligibility, by clinician assessment[discharge]