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New treatment option for Abdominal Aortic Aneurysm
Official title First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients
ClinicalTrials.gov ID: NCT07020611
What this study is testing
- What it's testing
- 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.
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
- 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 commercial EVAR devices used
- ≥18 years old
- Abdominal aortic aneurysm with sac diameter ≥ 5.5cm in males and ≥ 5.0cm in females
You likely can't join if
- Concomitant Common Iliac Artery aneurysms ≥ 25mm
- Life expectancy \<2 years
- Already participating in an investigational drug or device study
- Known allergy or contraindication to any study device material
- Coagulopathy or uncontrolled bleeding disorder
- Ruptured, leaking, inflammatory or mycotic aneurysm
See the full eligibility 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 commercial EVAR devices used
- ≥18 years old
- Abdominal aortic aneurysm with sac diameter ≥ 5.5cm in males and ≥ 5.0cm in females
- Maximum blood flow luminal diameter ≤ 50mm
- Eligible for endovascular aneurysm repair based on anatomical considerations, such as adequate iliac/femoral access
- Patient is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.
- Concomitant Common Iliac Artery aneurysms ≥ 25mm
- Life expectancy \<2 years
- Already participating in an investigational drug or device study
- Known allergy or contraindication to any study device material
- Coagulopathy or uncontrolled bleeding disorder
- Ruptured, leaking, inflammatory or mycotic aneurysm
- Connective tissue diseases (e.g., Marfan Syndrome)
- Unsuitable vascular anatomy that may interfere with device introduction or deployment, in the opinion of the investigator
- Aneurysmal or dissected disease of the descending thoracic aorta
- Previous surgical or EVAR repair for AAA
- Myocardial infarction and/or major heart surgery ≤ 90 days prior to the procedure
- Transient Ischemic Attack or stroke ≤ 90 days prior to the procedure
- Unstable angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease ≤ 30 days prior to the procedure
- Unable or unwilling to comply with study follow-up requirements
- Serum creatinine level ≥ 180 µmol/L
- Patients of childbearing potential who are pregnant or planning to become pregnant during the course of the study
- Patient has other medical, social or psychological problems that, in the opinion of the investigator, study involvement would not be in their best interest.
The study team makes the final eligibility decision.
Where it's taking place
- Auckland, New Zealand
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 Auckland, New Zealand. 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.