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New treatment option for Aneurysm, Abdominal Aortic
Official title First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms
ClinicalTrials.gov ID: NCT07330752
What this study is testing
- What it's testing
- This clinical trial evaluates the safety and feasibility of the A3-Shield implant for stabilising small abdominal aortic aneurysms in adult patients. The study enrolls men and women with small, asymptomatic infrarenal abdominal aortic aneurysms who are eligible for an elective catheter-based procedure.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- IC1. Male and female people ≥ 18 years at the time of screening. Female people must be of non-childbearing potential or otherwise not pregnant and...
- Aneurysm size of 3.0-5.0 cm in maximum diameter for males; 3.0 - 4.5 for females (diameter measured in CTA perpendicular to the line of flow)
- Aortic neck diameter ≥17mm and ≤ 29mm
- Adequate landing zone for a tubular device of ≥ 30 mm length IC3. Access vessel size and morphology allows endovascular access of 14F (or larger)...
You likely can't join if
- EC1. Subject has an aneurysm that is:
- symptomatic
- ruptured
- thoracic
- suprarenal
- thoraco-abdominal
See the full eligibility criteria
- IC1. Male and female people ≥ 18 years at the time of screening. Female people must be of non-childbearing potential or otherwise not pregnant and not planning to become pregnant during the study follow-up period. IC2...
- Aneurysm size of 3.0-5.0 cm in maximum diameter for males; 3.0 - 4.5 for females (diameter measured in CTA perpendicular to the line of flow)
- Aortic neck diameter ≥17mm and ≤ 29mm
- Adequate landing zone for a tubular device of ≥ 30 mm length IC3. Access vessel size and morphology allows endovascular access of 14F (or larger) introducer sheaths and catheters IC4. Subject (or legal representative)...
- EC1. Subject has an aneurysm that is:
- symptomatic
- ruptured
- thoracic
- suprarenal
- thoraco-abdominal
- isolated ilio-femoral
- mycotic
- inflammatory
- pseudoaneurysmatic
- traumatic EC2. Subject has any type of aortic dissection. EC3. Subject has congenital connective tissue disease, e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome. EC4. Subject has significant (\>25% of vessel...
The study team makes the final eligibility decision.
Where it's taking place
- Tashkent, Uzbekistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tashkent, Uzbekistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.