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

3-D Matrix

Status: Completed

Conditions: Vascular Anastomosis Surgery

Treatments: Device: PuraStat®

Study type: Observational

Funder types: Industry

Identifiers

NCT03103282

PuraStat-002-VASC

Details and patient eligibility

About

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.

Full 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).

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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
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

Trial design