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.

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.

Study Overview

• Status: Completed
• Conditions: Vascular Anastomosis Surgery
• Intervention / Treatment: Device: PuraStat®

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).

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • St George's University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®

Description

Main Inclusion criteria:

1. Male or female patient ≥18 years old
2. Subject undergoing elective carotid endarterectomy
3. Subject who is able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained
4. Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up
5. Intra-operative inclusion criteria: Subject requiring the use of PuraStat® for haemostasis during elective carotid endarterectomy either by direct closure (without the use of patch), or by patch reconstruction or eversion technique when haemostasis by ligation or standard means is insufficient or impractical.

Main exclusion criteria:

1. Presence or sequelae of coagulation disorder
2. Known allergy or hypersensitivity to any component of PuraStat®
3. Concurrent participation in another clinical trial with a medical device or a medicinal product

4. Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding

   Intra-operative exclusion criteria:

5. Spurting and/or gushing haemorrhage site(s)
6. Contaminated or potentially contaminated surgical area
7. Fibrin glue and/or topical haemostatic agent used before or concomitantly to the use of PuraStat®
8. Persistent major bleeding after conventional haemostasis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Time-To-Haemostasis	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®.	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Status Post Application(s)	Intraoperatively
Blood Loss	Intraoperatively
Total Drainage Volume	Post-operatively
Transfusion of Blood Products	Intraoperatively
Transfusion of Blood Products	Post-operatively
Quantity of Blood Product(s) and or Substitute(s)	Intraoperatively
Assessment of Product Use	Intraoperatively
Length of Hospital Stay	Discharge

Collaborators and Investigators

• Sponsor: 3-D Matrix Europe SAS

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): July 5, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: PuraStat-002-VASC