NCT03103282

Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: 3-D Matrix Europe SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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).

Conditions

• Vascular Anastomosis Surgery

Interventions

Type	Name	Description
DEVICE	PuraStat®	Synthetic haemostatic material

Timeline

• Start date: 2017-06-14
• Primary completion: 2019-07-05
• Completion: 2019-08-30
• First posted: 2017-04-06
• Last updated: 2020-12-10
• Results posted: 2020-12-10

Locations

1 site across 1 country: United Kingdom