Abdominal Aortic AneurysmASCENDNCT07020611
First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients
A study testing Cygnum Aneurysm Sac Management Device (ASMD) in people with Abdominal Aortic Aneurysm, run by Life Seal Vascular Inc. at 1 site in New Zealand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Cygnum Aneurysm Sac Management Device (ASMD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNew Zealand
- Study dates
- 26 Nov 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland
Helen Knight, +64 22 678 0040, helen@veraresearch.nz
About this study
Official title: Aneurysm SaC ManagemENt Device for Abdominal Aortic Aneurysms First-in-Human (ASCEND) Study
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:
- Is the Cygnum device safe when used adjunctively with standard EVAR endografts?
- Does it effectively reduce or prevent type II endoleaks by managing the aneurysm sac?
Participants will:
- Undergo EVAR with adjunctive implantation of the Cygnum device
- Have follow-up imaging (e.g., CT scans) and clinical assessments to evaluate device position and sac behavior over time
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Cygnum Aneurysm Sac Management Device (ASMD)
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cygnum Aneurysm Sac Management Device (ASMD)Device
Cygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks
| Study group | Role | What they receive |
|---|---|---|
| Cygnum ASMD Arm | Experimental | Not described Receives: Device: Cygnum Aneurysm Sac Management Device (ASMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse events (MAEs)
Rate of related major adverse events (MAEs)
Measured: 30 days post-procedure
Procedural Technical Success
Technical success, defined as lining the AAA sac wall with the investigational devices
Measured: Immediately after the intervention
Secondary outcomes (4)
Incidence of related major adverse events (MAEs)
Incidence rate of related major adverse events (MAEs)
Measured: 12 months post procedure
Incidence of related serious adverse events (SAEs)
Incidence rate of related serious adverse events (SAEs)
Measured: 12 months post procedure
Efficacy - Type II endoleaks
Incidence of type II endoleaks
Measured: 12 months post procedure
Efficacy - AAA sac diameter
Change in AAA sac diameter
Measured: 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start26 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life Seal Vascular Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Auckland City Hospital
- Responsible party
- Sponsor
- Investigators
- Raja Ghanem, Study director, Life Seal Vascular Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020611
- Sponsor's protocol ID
- CP-0001
- Acronym
- ASCEND
- Status last verified
- Dec 2025
- First submitted
- 27 May 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysm SaC ManagemENt Device for Abdominal Aortic Aneurysms First-in-Human (ASCEND) Study
- ClinicalTrials.gov ID
- NCT07020611
- Acronym / sponsor ID
- ASCEND / CP-0001
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Life Seal Vascular Inc.Industry (pharma, biotech, devices)
- Collaborators
- Auckland City Hospital
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the Cygnum device safe when used adjunctively with standard EVAR endografts?
- Does it effectively reduce or prevent type II endoleaks by managing the aneurysm sac?
Participants will:
- Undergo EVAR with adjunctive implantation of the Cygnum device
- Have follow-up imaging (e.g., CT scans) and clinical assessments to evaluate device position and sac behavior over time
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cygnum ASMD Arm | Experimental | Device: Cygnum Aneurysm Sac Management Device (ASMD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cygnum Aneurysm Sac Management Device (ASMD)Cygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks | Device | Cygnum ASMD Arm |
Primary outcome
Incidence of major adverse events (MAEs)
Time frame: 30 days post-procedure
Rate of related major adverse events (MAEs)
Procedural Technical Success
Time frame: Immediately after the intervention
Technical success, defined as lining the AAA sac wall with the investigational devices
4 secondary outcomes
Incidence of related major adverse events (MAEs)
Time frame: 12 months post procedure
Incidence of related serious adverse events (SAEs)
Time frame: 12 months post procedure
Efficacy - Type II endoleaks
Time frame: 12 months post procedure
Efficacy - AAA sac diameter
Time frame: 12 months post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raja Ghanem study director
Life Seal Vascular Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cygnum Aneurysm Sac Management Device (ASMD) in people with Abdominal Aortic Aneurysm, run by Life Seal Vascular Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raja N Ghanem (612-840-2723, contact@lifesealvascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse events (MAEs) (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.