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

FLOWGRAFT - 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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Heike Fischer, Dr.; Phone Number: +4915115397110; Email: fischer.heike@cryolife.com
• Study Contact Backup: Name: Alexander Oberhuber, Prof. Dr.; Phone Number: +49 251 83-45782; Email: alexander.oberhuber@ukmuenster.de

Study Locations

• Germany
  • NRW
    • Münster, NRW, Germany, 48149
      • Recruiting
      • Universitätsklinikum Münster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of in-hospital all-cause mortality	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Rate of all-cause mortality	30-day, 6-month,12-month, 24-month, 36-month, 60-month
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
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
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
Vascular Graft primary patency	Rate of patients with Vascular Graft primary patency	6-month,12-month, 24-month, 36-month, 60-month
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
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
Vascular Graft infection	Rate of patients with vascular Graft infection	6-month,12-month, 24-month, 36-month, 60-month
New sepsis	Rate of patients with new sepsis	6-month,12-month, 24-month, 36-month, 60-month
New stroke	Rate of patients with new stroke	6-month,12-month, 24-month, 36-month, 60-month

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Investigators: Principal Investigator: Alexander Oberhuber, Prof. Dr., University Hospital Münster

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): March 30, 2030

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: aneurysm; aortic; stenosis; dissection; PAU; IMH
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: FLOWGRAFT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No