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

Launched by JOTEC GMBH · Nov 25, 2021

Keywords

ClinConnect Summary

The FLOWGRAFT study is looking at the safety and effectiveness of special medical devices called vascular grafts, which are used to treat various problems in the arteries, such as blockages or bulges. These grafts are designed to help patients with conditions like aortic dissection, aneurysms, and other vascular issues. If you or a loved one is over 18 and has been recommended for treatment with one of these grafts from the company JOTEC, you may be eligible to participate in this study.

Participants in this trial will undergo regular check-ups and will need to provide informed consent, meaning they agree to take part after understanding the study. The main goal is to see how well these grafts work and to ensure they are safe for patients. It’s important to note that individuals with certain medical or psychological issues, or those scheduled for specific artery surgeries, may not qualify for this study. Overall, this trial is a chance to contribute to medical knowledge while receiving care for vascular diseases.

Gender

ALL

Eligibility criteria

• 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