An observational study in Vascular Diseases, sponsored by JOTEC GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-19.
Sponsored by JOTEC GmbH · Observational
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.
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.
694 studies on the registry are indexed under Vascular Diseases; 128 are open to participants now.
This study's planned enrollment of 500 is above the median of 200 across 218 observational studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →JOTEC GmbH is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient satisfies at least one of the following categories:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open repair of the aorta and peripheral arteries
Also known as: Open repair of the aorta and peripheral arteries
Mortality
Rate of in-hospital all-cause mortality
Time frame: 30-day
All-cause mortality
Rate of all-cause mortality
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft primary patency
Rate of patients with Vascular Graft primary patency
Time frame: 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)
Time frame: 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
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Vascular Graft infection
Rate of patients with vascular Graft infection
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
New sepsis
Rate of patients with new sepsis
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
New stroke
Rate of patients with new stroke
Time frame: 6-month,12-month, 24-month, 36-month, 60-month
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2021 (actual). Primary completion is estimated for Oct 2024, 33 months after the start.
Of 100 observational studies under Vascular Diseases, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 128. This study's planned 33 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
JOTEC GmbH