An observational study in Vascular Anastomosis Surgery, sponsored by 3-D Matrix Europe SAS. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by 3-D Matrix Europe SAS · Observational
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.
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).
3-D Matrix Europe SAS is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®
Main Inclusion criteria:
Main exclusion criteria:
Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding
Intra-operative exclusion criteria:
Synthetic haemostatic material
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®.
Time frame: Intraoperatively
Status Post Application(s)
Time frame: Intraoperatively
Blood Loss
Time frame: Intraoperatively
Total Drainage Volume
Time frame: Post-operatively
Transfusion of Blood Products
Time frame: Intraoperatively
Transfusion of Blood Products
Time frame: Post-operatively
Quantity of Blood Product(s) and or Substitute(s)
Time frame: Intraoperatively
Assessment of Product Use
Time frame: Intraoperatively
Length of Hospital Stay
Time frame: Discharge
| Milestone | PuraStat® |
|---|---|
| Started | 65 |
| Completed | 65 |
| Not completed | 0 |
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®.
| Secondes | PuraStat® |
|---|---|
| Total Time-To-Haemostasis | 83 ± 105 |
| Participants | PuraStat® |
|---|---|
| Complete Haemostasis | 59 |
| Presence of bleeding | 6 |
| mL | PuraStat® |
|---|---|
| Blood Loss | 127.0 ± 111.4 |
| mL | PuraStat® |
|---|---|
| Total Drainage Volume | 50.1 ± 50.8 |
| Participants | PuraStat® |
|---|---|
| NO | 63 |
| YES | 2 |
| Participants | PuraStat® |
|---|---|
| NO | 65 |
| YES | 0 |
| mL | PuraStat® |
|---|---|
| Quantity of Blood Product(s) and or Substitute(s) | 580.0 ± 113.1 |
| Participants | PuraStat® |
|---|---|
| Ease of preparation — Excellent | 49 |
| Ease of preparation — Good | 16 |
| Ease of preparation — Fair | 0 |
| Ease of preparation — Poor | 0 |
| Ease of application — Excellent | 40 |
| Ease of application — Good | 25 |
| Ease of application — Fair | 0 |
| Ease of application — Poor | 0 |
| Days | PuraStat® |
|---|---|
| Length of Hospital Stay | 4.3 ± 11.0 |
Collected over At procedure, 1 day post-operative, 5-7 days post-operative, 1 month (± 15 days) post-operative. Non-serious events are listed at a 3.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PuraStat® | 1/65 (1.5%) | 7/65 (10.8%) | 20/65 (30.8%) |
| Event | PuraStat® |
|---|---|
| StrokeNervous system disorders | 3/65 |
| Post procedural haematomaInjury, poisoning and procedural complications | 1/65 |
| DeathGeneral disorders | 1/65 |
| PneumoniaInfections and infestations | 1/65 |
| BradycardiaCardiac disorders | 1/65 |
| Event | PuraStat® |
|---|---|
| OtherInjury, poisoning and procedural complications | 18/65 |
| Haemorrhage/HaematomaInjury, poisoning and procedural complications | 2/65 |
| Age, Continuous(Years) | PuraStat® |
|---|---|
| Mean | 71.8 ± 8.9 |
| Sex: Female, Male(Participants) | PuraStat® |
|---|---|
| Female | 51 |
| Male | 14 |
| Race and Ethnicity Not Collected(Participants) | PuraStat® |
|---|
| Region of Enrollment(participants) | PuraStat® |
|---|---|
| United Kingdom | 53 |
| Belgium | 12 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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