Vascular DiseasesFLOWGRAFTNCT05145517
A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
An observational study of Vascular Diseases, run by JOTEC GmbH at 1 site in Germany.
Trial summary
The FLOWGRAFT post-market clinical follow-up study is undertaken to show the safety and performance of FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore and FlowLine Bipore Heparin (combined named as Vascular Grafts) in the treatment of arterial diseases, such as dissection, aneurysm, intramural hematoma (IMH)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Open repair
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2021to 30 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients with arterial disease who are scheduled to be treated with a Vascular Graft according to the instructions for use and their physician's discretion in accordance with the inclusion and exclusion criteria.
Who may be able to join
- Patient ≥ 18 years at time of written informed consent
- Patient was selected for treatment with a commercially available Vascular Graft of JOTEC
- Patient satisfies at least one of the following categories:
- Acute (14 days) / subacute (15 - 90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb)
- Chronic (>90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb)
- Aneurysm in the aorta or peripheral artery / arteries (lower limb)
Show all 14Show fewer
- IMH in the aorta or peripheral artery / arteries (lower limb)
- PAU in the aorta or peripheral artery / arteries (lower limb)
- Contained rupture in the aorta or peripheral artery / arteries (lower limb)
- Stenosis in the aorta or peripheral artery / arteries (lower limb)
- Debranching of head vessels
- AV shunt
- Patient is willing and able to comply with all clinical study procedures and study visits.
- Patient has given written informed consent to participate in the study.
Who cannot join
- Patient has any other medical, social, or psychological problem that in the opinion of the investigator preclude them from receiving this treatment, procedures, and evaluations pre- and post-procedure.
- Patient is scheduled for reconstruction of the tibial artery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Alexander Oberhuber, Prof., +49 251 8345780
About this study
Official title: FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
The FLOWGRAFT post-market clinical follow-up study is undertaken to show the safety and performance of FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore and FlowLine Bipore Heparin (combined named as Vascular Grafts) in the treatment of arterial diseases, such as dissection, aneurysm, intramural hematoma (IMH), penetrating aortic ulcer (PAU), contained rupture, stenosis in the aorta or peripheral arteries (lower limbs). This includes the use of FlowWeave Bioseal or FlowNit Bioseal for debranching of the head vessels in an alone standing procedure. Furthermore, it includes the use of the FlowLine Bipore and FlowLine Bipore Heparin Grafts as arterious-venous (AV) shunt.
Read the detailed description
In this study, patients who receive a Vascular Graft for the treatment of arterial diseases (aneurysm, PAU, IMH, dissection, stenosis) of the aorta or peripheral arteries (lower limbs) or as an AV shunt will be observed. This includes patients in whom the Vascular Grafts are used for debranching or reconstruction of the head vessels. Participating physicians will be asked to provide the observations, that were collected during routine care. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient prior to data collection.
The period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the date of intervention for each patient.
- Conditions
- Vascular Diseases
- Being tested
- Open repair
- Keywords
- aortic, aneurysm, dissection, stenosis, PAU, IMH
- Medical subject headings
- Vascular Diseases, Aneurysm, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open repairDevice
Also called Open repair of the aorta and peripheral arteries
Open repair of the aorta and peripheral arteries
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Rate of in-hospital all-cause mortality
Measured: 30-day
Secondary outcomes (10)
All-cause mortality
Rate of all-cause mortality
Measured: 30-day, 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft-related adverse event
Rate of patients with Vascular Graft-related adverse event
Measured: 30-day, 6-month,12-month, 24-month, 36-month, 60-month
Freedom from Vascular Graft -related hemorrhage
Rate of patients with freedom from Vascular Graft -related hemorrhage
Measured: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft stenosis > 50% or occlusion
Rate of patients with Vascular Graft stenosis > 50% or occlusion
Measured: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft primary patency
Rate of patients with Vascular Graft primary patency
Measured: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft secondary patency (after reintervention)
Rate of patients with Vascular Graft secondary patency (after reintervention)
Measured: 6-month,12-month, 24-month, 36-month, 60-month
Pseudoaneurysm at the sutures or in the Vascular Graft
Rate of patients with pseudoaneurysm at the sutures or in the Vascular Graft
Measured: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft infection
Rate of patients with vascular Graft infection
Measured: 6-month,12-month, 24-month, 36-month, 60-month
New sepsis
Rate of patients with new sepsis
Measured: 6-month,12-month, 24-month, 36-month, 60-month
New stroke
Rate of patients with new stroke
Measured: 6-month,12-month, 24-month, 36-month, 60-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start6 Dec 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by JOTEC GmbHThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Oberhuber, Prof. Dr., Principal investigator, University hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145517
- Sponsor's protocol ID
- FLOWGRAFT
- Acronym
- FLOWGRAFT
- Status last verified
- May 2022
- First submitted
- 25 Nov 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
- ClinicalTrials.gov ID
- NCT05145517
- Acronym / sponsor ID
- FLOWGRAFT / FLOWGRAFT
- Conditions
- Vascular Diseases
- Keywords
- aortic, aneurysm, dissection, stenosis, PAU, IMH
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FLOWGRAFT post-market clinical follow-up study is undertaken to show the safety and performance of FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore and FlowLine Bipore Heparin (combined named as Vascular Grafts) in the treatment of arterial diseases, such as dissection, aneurysm, intramural hematoma (IMH), penetrating aortic ulcer (PAU), contained rupture, stenosis in the aorta or peripheral arteries (lower limbs). This includes the use of FlowWeave Bioseal or FlowNit Bioseal for debranching of the head vessels in an alone standing procedure. Furthermore, it includes the use of the FlowLine Bipore and FlowLine Bipore Heparin Grafts as arterious-venous (AV) shunt.
Detailed description
In this study, patients who receive a Vascular Graft for the treatment of arterial diseases (aneurysm, PAU, IMH, dissection, stenosis) of the aorta or peripheral arteries (lower limbs) or as an AV shunt will be observed. This includes patients in whom the Vascular Grafts are used for debranching or reconstruction of the head vessels. Participating physicians will be asked to provide the observations, that were collected during routine care. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient prior to data collection.
The period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the date of intervention for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with arterial disease who are scheduled to be treated with a Vascular Graft according to the instructions for use and their physician's discretion in accordance with the inclusion and exclusion criteria.
Key inclusion criteria (14 listed)
- Patient ≥ 18 years at time of written informed consent
- Patient was selected for treatment with a commercially available Vascular Graft of JOTEC
- Patient satisfies at least one of the following categories:
- Patient is willing and able to comply with all clinical study procedures and study visits.
- Patient has given written informed consent to participate in the study.
Key exclusion criteria (2 listed)
- Patient has any other medical, social, or psychological problem that in the opinion of the investigator preclude them from receiving this treatment, procedures, and evaluations pre- and post-procedure.
- Patient is scheduled for reconstruction of the tibial artery
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 |
|---|---|---|
| Open repairAlso: Open repair of the aorta and peripheral arteriesOpen repair of the aorta and peripheral arteries | Device | – |
Primary outcome
Mortality
Time frame: 30-day
Rate of in-hospital all-cause mortality
10 secondary outcomes
All-cause mortality
Time frame: 30-day, 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft-related adverse event
Time frame: 30-day, 6-month,12-month, 24-month, 36-month, 60-month
Freedom from Vascular Graft -related hemorrhage
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft stenosis > 50% or occlusion
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft primary patency
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft secondary patency (after reintervention)
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Pseudoaneurysm at the sutures or in the Vascular Graft
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft infection
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
New sepsis
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
New stroke
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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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.
Alexander Oberhuber, Prof. Dr. principal investigator
University hospital Münster
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 Diseases, run by JOTEC GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 19 May 2022. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heike Fischer, Dr. (+4915115397110, fischer.heike@cryolife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30-day). 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 19 May 2022.