Observational follow-up for patients treated with vascular grafts
FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
This study looks at how well different types of vascular grafts work and how safe they are for patients with artery problems over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | JOTEC GmbH Industry-sponsored |
| Locations | 1 site (Münster, North Rhine-Westphalia) |
| Trial ID | NCT05145517 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and performance of various vascular grafts in patients with arterial diseases, including aneurysms, dissections, and stenosis. Patients who have received these grafts will be monitored over a period of approximately 60 months, with data collected during routine care. The study will involve gathering clinical observations from participating physicians after obtaining informed consent from patients. The focus is on understanding the long-term outcomes associated with these grafts in treating vascular conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have been selected for treatment with a JOTEC vascular graft for specific arterial conditions.
Not a fit: Patients with vascular conditions not requiring a graft or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of vascular grafts, potentially improving treatment strategies for patients with vascular diseases.
How similar studies have performed: Other studies have shown success in monitoring the outcomes of vascular grafts, suggesting that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Münster, North Rhine-Westphalia
- Universitätsklinikum Münster — Münster, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Alexander Oberhuber, Prof. Dr. — University hospital Münster
- Study coordinator: Heike Fischer, Dr.
- Email: fischer.heike@cryolife.com
- Phone: +4915115397110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.