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

Vascular Diseases Clinical Trial

— FLOWGRAFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145517
• Other study ID #: FLOWGRAFT
• Status: Recruiting
• Start date: December 6, 2021
• Est. completion date: March 30, 2030

Study information

• Verified date: May 2022
• Source: JOTEC GmbH
• Contact: Heike Fischer, Dr.
• Phone: +4915115397110
• Email: fischer.heike[@]cryolife.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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), 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 30, 2030
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• Open repair
Open repair of the aorta and peripheral arteries

Locations

Country	Name	City	State
Germany	Universitätsklinikum Münster	Münster	NRW

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Rate of in-hospital all-cause mortality	30-day
Secondary	All-cause mortality	Rate of all-cause mortality	30-day, 6-month,12-month, 24-month, 36-month, 60-month
Secondary	Vascular Graft-related adverse event	Rate of patients with Vascular Graft-related adverse event	30-day, 6-month,12-month, 24-month, 36-month, 60-month
Secondary	Freedom from Vascular Graft -related hemorrhage	Rate of patients with freedom from Vascular Graft -related hemorrhage	6-month,12-month, 24-month, 36-month, 60-month
Secondary	Vascular Graft stenosis > 50% or occlusion	Rate of patients with Vascular Graft stenosis > 50% or occlusion	6-month,12-month, 24-month, 36-month, 60-month
Secondary	Vascular Graft primary patency	Rate of patients with Vascular Graft primary patency	6-month,12-month, 24-month, 36-month, 60-month
Secondary	Vascular Graft secondary patency (after reintervention)	Rate of patients with Vascular Graft secondary patency (after reintervention)	6-month,12-month, 24-month, 36-month, 60-month
Secondary	Pseudoaneurysm at the sutures or in the Vascular Graft	Rate of patients with pseudoaneurysm at the sutures or in the Vascular Graft	6-month,12-month, 24-month, 36-month, 60-month
Secondary	Vascular Graft infection	Rate of patients with vascular Graft infection	6-month,12-month, 24-month, 36-month, 60-month
Secondary	New sepsis	Rate of patients with new sepsis	6-month,12-month, 24-month, 36-month, 60-month
Secondary	New stroke	Rate of patients with new stroke	6-month,12-month, 24-month, 36-month, 60-month