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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103282
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
3-D Matrix Europe SAS

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.

Condition or disease Intervention/treatment
Vascular Anastomosis Surgery Device: PuraStat®

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : July 5, 2019
Estimated Study Completion Date : September 30, 2019

Intervention Details:
  • Device: PuraStat®
    Synthetic haemostatic material


Primary Outcome Measures :
  1. Total Time-To-Haemostasis [ Time Frame: Intraoperatively ]
    Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been previously treated with PuraStat®
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103282


Locations
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United Kingdom
St George'S University Hospitals Nhs Foundation Trust
London, United Kingdom
Sponsors and Collaborators
3-D Matrix Europe SAS
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Responsible Party: 3-D Matrix Europe SAS
ClinicalTrials.gov Identifier: NCT03103282    
Other Study ID Numbers: PuraStat-002-VASC
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes