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

NCT03103282 | Completed Results

• 1 other identifier: PuraStat-002-VASC
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Anastomosis Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Status Post Application(s)

  Intraoperatively

• Blood Loss

  Intraoperatively

• Total Drainage Volume

  Post-operatively

• Transfusion of Blood Products

  Intraoperatively

• Transfusion of Blood Products

  Post-operatively

Interventions

PuraStat® DEVICE

Synthetic haemostatic material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female patient ≥18 years old
• Subject undergoing elective carotid endarterectomy
• Subject who is able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained
• 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

You may not qualify if:

• Presence or sequelae of coagulation disorder
• Known allergy or hypersensitivity to any component of PuraStat®
• Concurrent participation in another clinical trial with a medical device or a medicinal product
• Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding
• Spurting and/or gushing haemorrhage site(s)
• Contaminated or potentially contaminated surgical area
• Fibrin glue and/or topical haemostatic agent used before or concomitantly to the use of PuraStat®
• Persistent major bleeding after conventional haemostasis

Sponsors & Collaborators

• 3-D Matrix Europe SAS: lead

Study Sites (1)

St George'S University Hospitals Nhs Foundation Trust

London, United Kingdom

Location

Results Point of Contact

• Title: Florian REBECA
• Organization: 3-D Matrix Europe SAS

frebeca@puramatrix.com

+33617587769

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 6, 2017
• Study Start: June 14, 2017
• Primary Completion: July 5, 2019
• Study Completion: August 30, 2019
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-11

Locations

GB (1)