Vascular Anastomosis SurgeryNCT03103282
Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.
An observational study of Vascular Anastomosis Surgery, run by 3-D Matrix Europe SAS at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Anastomosis Surgery
- What is being tested?
- PuraStat®
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2017to 30 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George'S University Hospitals Nhs Foundation Trust
London
About this study
Official title: 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.
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.
Read the 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).
- Conditions
- Vascular Anastomosis Surgery
- Being tested
- PuraStat®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuraStat®Device
Synthetic haemostatic material
What is being measured
The primary outcome is the main question the study is designed to answer.
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®.
Measured: Intraoperatively
Secondary outcomes (8)
Status Post Application(s)
Measured: Intraoperatively
Blood Loss
Measured: Intraoperatively
Total Drainage Volume
Measured: Post-operatively
Transfusion of Blood Products
Measured: Intraoperatively
Transfusion of Blood Products
Measured: Post-operatively
Quantity of Blood Product(s) and or Substitute(s)
Measured: Intraoperatively
Assessment of Product Use
Measured: Intraoperatively
Length of Hospital Stay
Measured: Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start14 Jun 2017
- Primary completion5 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular Anastomosis SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-D Matrix Europe SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103282
- Sponsor's protocol ID
- PuraStat-002-VASC
- Status last verified
- Nov 2020
- First submitted
- 31 Mar 2017
- Last updated
- 10 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03103282
- Acronym / sponsor ID
- PuraStat-002-VASC
- Conditions
- Vascular Anastomosis Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- 3-D Matrix Europe SASIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PuraStat®Synthetic haemostatic material | Device | – |
Primary outcome
Total Time-To-Haemostasis
Time frame: 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®.
8 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Anastomosis Surgery, run by 3-D Matrix Europe SAS at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Time-To-Haemostasis (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.