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

November 13, 2020 updated by: 3-D Matrix Europe SAS

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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®.
Intraoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Status Post Application(s)
Time Frame: Intraoperatively
Intraoperatively
Blood Loss
Time Frame: Intraoperatively
Intraoperatively
Total Drainage Volume
Time Frame: Post-operatively
Post-operatively
Transfusion of Blood Products
Time Frame: Intraoperatively
Intraoperatively
Transfusion of Blood Products
Time Frame: Post-operatively
Post-operatively
Quantity of Blood Product(s) and or Substitute(s)
Time Frame: Intraoperatively
Intraoperatively
Assessment of Product Use
Time Frame: Intraoperatively
Intraoperatively
Length of Hospital Stay
Time Frame: Discharge
Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
3-D Matrix Europe SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PuraStat-002-VASC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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