Observational follow-up for patients treated with vascular grafts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.