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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03103282

Enrollment

Registered

2017-04-06

Start date

2017-06-14

Completion date

2019-08-30

Last updated

2020-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Anastomosis Surgery

Brief 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.

Detailed 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).

Interventions

DEVICEPuraStat®

Synthetic haemostatic material

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Total Time-To-Haemostasis	Intraoperatively	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®.

Secondary

Measure	Time frame
Blood Loss	Intraoperatively
Total Drainage Volume	Post-operatively
Transfusion of Blood Products	Intraoperatively
Status Post Application(s)	Intraoperatively
Assessment of Product Use	Intraoperatively
Length of Hospital Stay	Discharge
Quantity of Blood Product(s) and or Substitute(s)	Intraoperatively

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
PuraStat® Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®	65
Total	65

Baseline characteristics

Characteristic	PuraStat®	—
Age, Continuous	71.8 Years STANDARD_DEVIATION 8.9	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Belgium	12 participants	—
Region of Enrollment United Kingdom	53 participants	—
Sex: Female, Male Female	51 Participants	—
Sex: Female, Male Male	14 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 65
other Total, other adverse events	20 / 65
serious Total, serious adverse events	7 / 65

Outcome results

Primary

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

Arm	Measure	Value (MEAN)	Dispersion
PuraStat®	Total Time-To-Haemostasis	83 Secondes	Standard Deviation 105

Secondary

Assessment of Product Use

Time frame: Intraoperatively

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
PuraStat®	Assessment of Product Use	Ease of preparation	Excellent	49 Participants
PuraStat®	Assessment of Product Use	Ease of preparation	Good	16 Participants
PuraStat®	Assessment of Product Use	Ease of preparation	Fair	0 Participants
PuraStat®	Assessment of Product Use	Ease of preparation	Poor	0 Participants
PuraStat®	Assessment of Product Use	Ease of application	Excellent	40 Participants
PuraStat®	Assessment of Product Use	Ease of application	Good	25 Participants
PuraStat®	Assessment of Product Use	Ease of application	Fair	0 Participants
PuraStat®	Assessment of Product Use	Ease of application	Poor	0 Participants

Secondary

Blood Loss

Time frame: Intraoperatively

Arm	Measure	Value (MEAN)	Dispersion
PuraStat®	Blood Loss	127.0 mL	Standard Deviation 111.4

Secondary

Length of Hospital Stay

Time frame: Discharge

Arm	Measure	Value (MEAN)	Dispersion
PuraStat®	Length of Hospital Stay	4.3 Days	Standard Deviation 11

Secondary

Quantity of Blood Product(s) and or Substitute(s)

Time frame: Intraoperatively

Arm	Measure	Value (MEAN)	Dispersion
PuraStat®	Quantity of Blood Product(s) and or Substitute(s)	580.0 mL	Standard Deviation 113.1

Secondary

Status Post Application(s)

Time frame: Intraoperatively

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
PuraStat®	Status Post Application(s)	Complete Haemostasis	59 Participants
PuraStat®	Status Post Application(s)	Presence of bleeding	6 Participants

Secondary

Total Drainage Volume

Time frame: Post-operatively

Arm	Measure	Value (MEAN)	Dispersion
PuraStat®	Total Drainage Volume	50.1 mL	Standard Deviation 50.8

Secondary

Transfusion of Blood Products

Time frame: Post-operatively

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
PuraStat®	Transfusion of Blood Products	NO	65 Participants
PuraStat®	Transfusion of Blood Products	YES	0 Participants

Secondary

Transfusion of Blood Products

Time frame: Intraoperatively

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
PuraStat®	Transfusion of Blood Products	YES	2 Participants
PuraStat®	Transfusion of Blood Products	NO	63 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Total Time-To-Haemostasis

Assessment of Product Use

Blood Loss

Length of Hospital Stay

Quantity of Blood Product(s) and or Substitute(s)

Status Post Application(s)

Total Drainage Volume

Transfusion of Blood Products

Transfusion of Blood Products