First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients
Recruiting
N/A
Interventional Study
Abdominal Aortic Aneurysm
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- Life Seal Vascular Inc. · Industry
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About This Trial
The goal of this clinical trial is to evaluate the safety and feasibility of the Cygnum Aneurysm Sac Management Device in patients with abdominal aortic aneurysms treated with endovascular aneurysm repair (EVAR). The main questions it aims to answer are:
1. Is the Cygnum device safe when used adjunctively with standard EVAR endografts?
2. Does it effectively reduce or prevent type II endoleaks by…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent
* Patient is willing to complete the follow-up according to the requirements of the protocol.
* Patient AAA anatomy complies with "instructions for use" for comm…
Contacts