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

Study Overview
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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).

Official Title
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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.

Conditions
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Vascular Anastomosis Surgery

Intervention / Treatment
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* Device: PuraStat®


Participation Criteria
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Eligibility Criteria
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Main Inclusion criteria: 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 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: 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 Intra-operative exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PuraStat®|Synthetic haemostatic material|

What is the study measuring?
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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 | Measure Description | 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 |