N/A
N=65
Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.
Vascular Anastomosis Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03103282 ↗Enrolled (actual)
65
Serious AEs
10.8%
Results posted
Dec 2020
Primary outcome: Primary: Total Time-To-Haemostasis — 83 Secondes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PuraStat® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- 3-D Matrix Europe SAS
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Time-To-Haemostasis |
83 | — |
| SECONDARY Status Post Application(s) |
59; 6 | — |
| SECONDARY Blood Loss |
127.0 | — |
| SECONDARY Total Drainage Volume |
50.1 | — |
| SECONDARY Transfusion of Blood Products |
65; 0 | — |
| SECONDARY Transfusion of Blood Products |
65; 0 | — |
| SECONDARY Quantity of Blood Product(s) and or Substitute(s) |
580.0 | — |
| SECONDARY Assessment of Product Use |
49; 16; 0; 0; 40; 25 | — |
| SECONDARY Length of Hospital Stay |
4.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03103282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.