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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-14

Study Completion Date

2019-08-30

Brief Summary

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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

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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

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Vascular Anastomosis Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PuraStat®

Synthetic haemostatic material

Intervention Type DEVICE

Eligibility Criteria

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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

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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St George'S University Hospitals Nhs Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Statistical Analysis Plan

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Document Type: Study Protocol