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

Sponsor

JOTEC GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05145517

Collaborator

(none)

500

Enrollment

Location

99.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases	Device: Open repair

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 6, 2021

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Mar 30, 2030

Outcome Measures

Primary Outcome Measures

Mortality [30-day]
Rate of in-hospital all-cause mortality

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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