Clinical trial NCT05145517: A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
Official title: FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Diseases
Keywords: aortic
aneurysm
dissection
stenosis
PAU
IMH
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2021-12-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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), 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.

Eligibility criteria: Inclusion Criteria:

* 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)
  * 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mortality
timeFrame: 30-day
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30-day, 6-month,12-month, 24-month, 36-month, 60-month
measure: Vascular Graft-related adverse event
timeFrame: 30-day, 6-month,12-month, 24-month, 36-month, 60-month
measure: Freedom from Vascular Graft -related hemorrhage
timeFrame: 6-month,12-month, 24-month, 36-month, 60-month
measure: Vascular Graft stenosis > 50% or occlusion
timeFrame: 6-month,12-month, 24-month, 36-month, 60-month
measure: Vascular Graft primary patency
timeFrame: 6-month,12-month, 24-month, 36-month, 60-month
measure: Vascular Graft secondary patency (after reintervention)
timeFrame: 6-month,12-month, 24-month, 36-month, 60-month
measure: Pseudoaneurysm at the sutures or in the Vascular Graft
timeFrame: 6-month,12-month, 24-month, 36-month, 60-month
measure: Vascular Graft infection
timeFrame: 6-month,12-month, 24-month, 36-month, 60-month
measure: New sepsis
timeFrame: 6-month,12-month, 24-month, 36-month, 60-month
measure: New stroke
timeFrame: 6-month,12-month, 24-month, 36-month, 60-month
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: NRW
Study officials:
affiliation: University hospital Münster
name: Alexander Oberhuber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: