A Multi-center, Single Arm Post-market Clinical Study to Confirm Safety and Performance of PuraStat® Absorbable Haemostatic Material for the Management of Bleeding In Vascular Surgery.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vascular Anastomosis Surgery
- Sponsor
- 3-D Matrix Europe SAS
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Total Time-To-Haemostasis
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
Detailed Description
This multicentre, single arm post-market clinical study aims to collect medical information on patients implanted with PuraStat®, Absorbable Haemostatic Material, according to each participating institution's procedures and standards of care for confirming the safety and the performance of PuraStat®, for the management of bleeding in vascular surgery (Carotid Endarterectomy either by direct closure (without the use of patch), or by patch reconstruction or eversion technique).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Total Time-To-Haemostasis
Time Frame: Intraoperatively
Total Time-To-Haemostasis (TTH) will be intraoperatively measured (secondes) from the first application of PuraStat® to a bleeding site after clamp release, until all bleeding at that site has ceased. In case of rebleeding of the treated sites and additional application of PuraStat®, the TTH will be calculated by the addition of TTH1+ TTH(n+1), where TTH1+ TTH(n+1) are the time to haemostasis after each application of PuraStat®.
Secondary Outcomes
- Quantity of Blood Product(s) and or Substitute(s)(Intraoperatively)
- Status Post Application(s)(Intraoperatively)
- Assessment of Product Use(Intraoperatively)
- Length of Hospital Stay(Discharge)
- Blood Loss(Intraoperatively)
- Total Drainage Volume(Post-operatively)
- Transfusion of Blood Products(Post-operatively)