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

Study acronym: FLOWGRAFT
StatusRecruiting
PhaseNot specified
SponsorJOTEC GmbH
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 19, 2022 (before its estimated October 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
JOTEC GmbH
14 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT05145517
Lead Sponsor JOTEC GmbH
Conditions
(from sponsor)		 Vascular Diseases
Related terms Aneurysm, Constriction, Pathologic, Vascular Diseases
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov