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NCT Number: NCT05145517

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location status: Recruiting

Location contact

Alexander Oberhuber, Prof.

CONTACT

+49 251 8345780

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open repair

Device

Open repair of the aorta and peripheral arteries

Other names: Open repair of the aorta and peripheral arteries

Primary outcomes

  1. Mortality

    Time frame: 30-day

    Rate of in-hospital all-cause mortality

Secondary outcomes

  1. All-cause mortality

    Time frame: 30-day, 6-month,12-month, 24-month, 36-month, 60-month

    Rate of all-cause mortality

  2. Vascular Graft-related adverse event

    Time frame: 30-day, 6-month,12-month, 24-month, 36-month, 60-month

    Rate of patients with Vascular Graft-related adverse event

  3. Freedom from Vascular Graft -related hemorrhage

    Time frame: 6-month,12-month, 24-month, 36-month, 60-month

    Rate of patients with freedom from Vascular Graft -related hemorrhage

  4. Vascular Graft stenosis > 50% or occlusion

    Time frame: 6-month,12-month, 24-month, 36-month, 60-month

    Rate of patients with Vascular Graft stenosis > 50% or occlusion

  5. Vascular Graft primary patency

    Time frame: 6-month,12-month, 24-month, 36-month, 60-month

    Rate of patients with Vascular Graft primary patency

  6. Vascular Graft secondary patency (after reintervention)

    Time frame: 6-month,12-month, 24-month, 36-month, 60-month

    Rate of patients with Vascular Graft secondary patency (after reintervention)

  7. Pseudoaneurysm at the sutures or in the Vascular Graft

    Time frame: 6-month,12-month, 24-month, 36-month, 60-month

    Rate of patients with pseudoaneurysm at the sutures or in the Vascular Graft

  8. Vascular Graft infection

    Time frame: 6-month,12-month, 24-month, 36-month, 60-month

    Rate of patients with vascular Graft infection

  9. New sepsis

    Time frame: 6-month,12-month, 24-month, 36-month, 60-month

    Rate of patients with new sepsis

  10. New stroke

    Time frame: 6-month,12-month, 24-month, 36-month, 60-month

    Rate of patients with new stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Oberhuber, Prof. Dr.

CONTACT

[email protected]

+49 251 83-45782

Heike Fischer, Dr.

CONTACT

[email protected]

+4915115397110

Sponsors and collaborators

Lead sponsor

JOTEC GmbH

Industry

Registry information

Official study title

FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts

Acronym: FLOWGRAFT

Important dates

Study start
2021
Primary completion
2024
Study completion
2030
First posted
Dec 6, 2021
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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