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

NCT05145517 | Recruiting

• 1 other identifier: FLOWGRAFT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases

Keywords

aortic; aneurysm; dissection; stenosis; PAU; IMH

Outcome Measures

Primary Outcomes (1)

• Mortality

  Rate of in-hospital all-cause mortality

  30-day

Secondary Outcomes (10)

• All-cause mortality

  30-day, 6-month,12-month, 24-month, 36-month, 60-month

• Vascular Graft-related adverse event

  30-day, 6-month,12-month, 24-month, 36-month, 60-month

• Freedom from Vascular Graft -related hemorrhage

  6-month,12-month, 24-month, 36-month, 60-month

• Vascular Graft stenosis > 50% or occlusion

  6-month,12-month, 24-month, 36-month, 60-month

• Vascular Graft primary patency

  6-month,12-month, 24-month, 36-month, 60-month

Interventions

Open repair DEVICE

Open repair of the aorta and peripheral arteries

Also known as: Open repair of the aorta and peripheral arteries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (1)

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Vascular Diseases; Aneurysm; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Oberhuber, Prof. Dr.

  University hospital Münster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heike Fischer, Dr.

CONTACT

+4915115397110; fischer.heike@cryolife.com

Alexander Oberhuber, Prof. Dr.

CONTACT

+49 251 83-45782; alexander.oberhuber@ukmuenster.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 6, 2021
• Study Start: December 6, 2021
• Primary Completion: October 1, 2024
• Study Completion (Estimated): March 30, 2030
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)