Aneurysm, Abdominal AorticPRINCIPIIS-FIHNCT07330752
First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms
A study testing A3-Shield Implantation in people with Aneurysm, Abdominal Aortic, run by Angiolutions GmbH at 1 site in Uzbekistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Abdominal Aortic
- What is being tested?
- A3-Shield Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUzbekistan
- Study dates
- 28 Nov 2025to Jul 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
- IC1. Male and female subjects ≥ 18 years at the time of screening. Female subjects must be of non-childbearing potential or otherwise not pregnant and not planning to become pregnant during the study follow-up period.
- IC2. Subject has a documented fusiform infrarenal abdominal aortic aneurysm characterized by the following:
- 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) understands the study requirements and the procedures and provided written informed consent.
- IC5. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow-up visits.
Who cannot join
- EC1. Subject has an aneurysm that is:
- symptomatic
- ruptured
- thoracic
- suprarenal
- thoraco-abdominal
Show all 30Show fewer
- 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 circumference of aortic neck) aortic mural thrombus at the attachment site that could compromise fixation of the device.
- EC5. Subject has arterial access that is not acceptable for the device delivery systems as defined in the device Instructions For Use.
- EC6. Subject has had an acute myocardial infarction within 180 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
- EC7. Subject has untreated coronary artery disease, which in the opinion of the treating physician, is clinically significant and requires revascularization.
- EC8. Subject has congestive heart failure (NYHA class III or IV) or high-grade valvular disease.
- EC9. Subject has had a cerebrovascular accident or transient ischemic attack within the past 90 days prior to study enrollment.
- EC10. Subject has end-stage renal disease or has a creatinine > 2.0 mg/dl or is on dialysis.
- EC11. Subject has a history of bleeding diathesis or coagulopathy.
- EC12. Subject has Hgb <9 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
- EC13. Subject has had or plans to have an unrelated major surgical or interventional procedure (including trans-aortic interventions) within 30 days prior or post implantation of the device.
- EC14. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to the device components.
- EC15. Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the informed consent form in this study.
- EC16. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented conditions that inhibit radiographic visualization of the aorta.
- EC17. Subject has an active infection or chronic systemic illness at the time of the index procedure that may interfere with study objectives.
- EC18. Subject has current problems with substance abuse.Smoking is NOT an exclusion criterion.
- EC19. Subject has severe incapacitating dementia.
- EC20. Subject has a life expectancy of less than 24 months due to comorbid conditions based on the assessment of the investigator at the time of enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uzbekistan1 site, 1 recruiting
- Recruiting
Еzgu Niyат Llc
Tashkent, 100027
Askar Sabirov, MD, 95 198 83 00, a.sabirov@gmail.com
About this study
Official title: PRemarket INvestigation to Evaluate the Clinical Safety and effectIveness of the Protective "A3- Shield" System for the stabIlIzation of Abdominal Aortic aneurysmS - Pilot Phase
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.
The trial aims to determine whether implantation of the A3-Shield device is technically feasible and whether it is associated with mechanical immobilization of the aneurysm neck. The study also assesses the peri-procedural and safety profile of the device.
Participants will undergo implantation of the A3-Shield device and attend scheduled follow-up visits that include clinical assessments and imaging such as ultrasound and computed tomography. The study does not include randomisation or a separate control group.
Read the detailed description
Current management of abdominal aortic aneurysms is severely limited by the lack of therapeutic options that can halt the underlying dilating biology. At present, there is no available intervention that can sufficiently intercept the size progression of small abdominal aortic aneurysms. This gap is highly relevant because the vast majority of abdominal aortic aneurysms are detected at a small size, and a substantial proportion of these aneurysms enlarge over the following years and eventually require prosthetic repair, which carries procedure-related and long-term risks. The limited efficacy of endovascular aortic repair in small aneurysms and the significant long-term complications observed in large aneurysms treated by endovascular aortic repair are thought to be related, at least in part, to insufficient control of aneurysm sac expansion. Effective stabilisation of aneurysm size at an early stage therefore represents a major unmet need in abdominal aortic aneurysm management.
The A3-Shield implant introduces a new approach to aneurysm treatment by targeting the biomechanical forces that contribute to aneurysm enlargement. Each heartbeat generates aortic pulse waves that propagate along the vessel and induce pulsatile wall motion. As these pulse waves reach the aneurysmal segment, they generate concentrated mechanical stress at the AAA shoulder region. This stress concentration is believed to promote further expansion of the aneurysm. The A3-Shield implant is designed to counteract this mechanism by mechanically immobilizing the aneurysm neck and gradually dampening the transmission of harmful pulse wave forces into the aneurysm sac, thereby aiming to protect the aneurysm from stress-induced enlargement.
This first-in-human clinical trial evaluates the safety and feasibility of the A3-Shield implant in adult patients with small infrarenal abdominal aortic aneurysms. The primary objectives are to determine whether the implantation procedure is technically feasible and whether it is associated with suppression of pulse wave transmission at the aneurysm neck. The study also assesses the peri-procedural and safety profile of the device.
Participants undergo a catheter-based implantation of the A3-Shield device under fluoroscopic guidance. Following the procedure, they attend scheduled follow-up visits that include clinical examinations and imaging such as ultrasound and computed tomography. The study does not include randomisation or a separate control group.
The findings from this pilot phase are intended to support further clinical development and may provide early evidence for a new interventional strategy that addresses an unmet need in the management of small abdominal aortic aneurysms.
- Conditions
- Aneurysm, Abdominal Aortic
- Being tested
- A3-Shield Implantation
- Keywords
- A3-Shield, Small AAA, Pulse Wave Modulation
- 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.
A3-Shield ImplantationDevice
Implantation of the A3-Shield Device in the AAA Neck
| Study group | Role | What they receive |
|---|---|---|
| Device implantation | Experimental | A3-Shield Implantation Receives: Device: A3-Shield Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint: Absence of Major Adverse Events
Absence of Major Adverse Events (MAEs). MAE is defined as a composite of death, stroke, myocardial infarction, new onset renal failure (requiring dialysis), respiratory failure (requiring mechanical ventilation), paralysis or paraparesis, bowel ischemia requiring surgical intervention or procedural blood loss ≥ 1,000 cc.
Measured: Within 30 days of the index procedure
Primary effectiveness endpoint: Successful aneurysm treatment
Successful aneurysm treatment defined as the composite of
- Technical success, defined as successful insertion of the delivery system through the vasculature, successful deployment of the device at the intended location, and successful removal of the delivery system
- Immobilization of the distal AAA neck, defined as aortic circumferential cyclic strain < 10% as measured via vascular ultrasound at the conclusion of the index procedure and assessed by an independent core laboratory
Measured: Conclusion of the index procedure
Secondary outcomes (9)
Secondary safety endpoint: Absence of Major Adverse Events
Absence of Major Adverse Events (MAEs)
Measured: 180 days, 12 months,vand 24 months post index procedure.
Secondary safety endpoint: Procedure related complications
Procedure related complications
Measured: 30 days, 6 months, 12 months, and 24 months post index procedure
Secondary safety endpoint: Device related complications
Device related complications. Device related complications are defined as device fracture(s), device migration, and device occlusion requiring intervention.
Measured: 30 days, 6 months, 12 months, and 24 months post index procedure
Secondary effectiveness endpoint: Freedom of aneurysmal sac enlargement
Freedom of aneurysmal sac enlargement. Enlargement is defined as a maximum diameter increase of > 5 mm per year, or aneurysm sac volume increase of > 10% per year, as assessed by CT scans and an independent core laboratory
Measured: Day 30, 12 months, and 24 months post index procedure
Secondary effectiveness endpoint: Aneurysmal sac shrinkage
Aneurysmal sac shrinkage. Shrinkage is defined as a maximum diameter decrease of > 5 mm per year, or aneurysm sac volume decrease of > 10% per year, as assessed by CT scans and an independent core laboratory
Measured: Day 30, 12 months, and 24 months post index procedure
Secondary effectiveness endpoint: Technical Success
Technical Success, defined as the presence of the device in the intended location and absence of device occlusion as assessed by CT scans and an independent core laboratory
Measured: Day 30
Secondary effectiveness endpoint: Immobilization of the distal AAA neck
Immobilization of the distal AAA neck, defined as aortic circumferential cyclic strain < 10% as measured via vascular ultrasound and assessed by an independent core laboratory
Measured: Day 30, 6 months, 12 months and 24 months
Secondary effectiveness endpoint: Absence of requirement of AAA repair
Absence of requirement of AAA repair (OR or EVAR)
Measured: 30 days, 6 months, 12 months, and 24 months post index procedure.
Secondary effectiveness endpoint: Absence of aneurysm related mortality
Absence of aneurysm related mortality
Measured: 6 months, 12 months, and 24 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start28 Nov 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm, Abdominal AorticStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angiolutions GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwe Raaz, MD, Study director, Angiolutions GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330752
- Sponsor's protocol ID
- AL-P001-2025
- Acronym
- PRINCIPIIS-FIH
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRemarket INvestigation to Evaluate the Clinical Safety and effectIveness of the Protective "A3- Shield" System for the stabIlIzation of Abdominal Aortic aneurysmS - Pilot Phase
- ClinicalTrials.gov ID
- NCT07330752
- Acronym / sponsor ID
- PRINCIPIIS-FIH / AL-P001-2025
- Conditions
- Aneurysm, Abdominal Aortic
- Keywords
- A3-Shield, Small AAA, Pulse Wave Modulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Angiolutions GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Jan 2026 (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.
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.
The trial aims to determine whether implantation of the A3-Shield device is technically feasible and whether it is associated with mechanical immobilization of the aneurysm neck. The study also assesses the peri-procedural and safety profile of the device.
Participants will undergo implantation of the A3-Shield device and attend scheduled follow-up visits that include clinical assessments and imaging such as ultrasound and computed tomography. The study does not include randomisation or a separate control group.
Detailed description
Current management of abdominal aortic aneurysms is severely limited by the lack of therapeutic options that can halt the underlying dilating biology. At present, there is no available intervention that can sufficiently intercept the size progression of small abdominal aortic aneurysms. This gap is highly relevant because the vast majority of abdominal aortic aneurysms are detected at a small size, and a substantial proportion of these aneurysms enlarge over the following years and eventually require prosthetic repair, which carries procedure-related and long-term risks. The limited efficacy of endovascular aortic repair in small aneurysms and the significant long-term complications observed in large aneurysms treated by endovascular aortic repair are thought to be related, at least in part, to insufficient control of aneurysm sac expansion. Effective stabilisation of aneurysm size at an early stage therefore represents a major unmet need in abdominal aortic aneurysm management.
The A3-Shield implant introduces a new approach to aneurysm treatment by targeting the biomechanical forces that contribute to aneurysm enlargement. Each heartbeat generates aortic pulse waves that propagate along the vessel and induce pulsatile wall motion. As these pulse waves reach the aneurysmal segment, they generate concentrated mechanical stress at the AAA shoulder region. This stress concentration is believed to promote further expansion of the aneurysm. The A3-Shield implant is designed to counteract this mechanism by mechanically immobilizing the aneurysm neck and gradually dampening the transmission of harmful pulse wave forces into the aneurysm sac, thereby aiming to protect the aneurysm from stress-induced enlargement.
This first-in-human clinical trial evaluates the safety and feasibility of the A3-Shield implant in adult patients with small infrarenal abdominal aortic aneurysms. The primary objectives are to determine whether the implantation procedure is technically feasible and whether it is associated with suppression of pulse wave transmission at the aneurysm neck. The study also assesses the peri-procedural and safety profile of the device.
Participants undergo a catheter-based implantation of the A3-Shield device under fluoroscopic guidance. Following the procedure, they attend scheduled follow-up visits that include clinical examinations and imaging such as ultrasound and computed tomography. The study does not include randomisation or a separate control group.
The findings from this pilot phase are intended to support further clinical development and may provide early evidence for a new interventional strategy that addresses an unmet need in the management of small abdominal aortic aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device implantation | Experimental | Device: A3-Shield ImplantationA3-Shield Implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- IC1. Male and female subjects ≥ 18 years at the time of screening. Female subjects must be of non-childbearing potential or otherwise not pregnant and not planning to become pregnant during the study follow-up period.
- IC2. Subject has a documented fusiform infrarenal abdominal aortic aneurysm characterized by the following:
- 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
Key exclusion criteria (30 listed)
- symptomatic
- ruptured
- thoracic
- suprarenal
- thoraco-abdominal
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 |
|---|---|---|
| A3-Shield ImplantationImplantation of the A3-Shield Device in the AAA Neck | Device | Device implantation |
Primary outcome
Primary safety endpoint: Absence of Major Adverse Events
Time frame: Within 30 days of the index procedure
Absence of Major Adverse Events (MAEs). MAE is defined as a composite of death, stroke, myocardial infarction, new onset renal failure (requiring dialysis), respiratory failure (requiring mechanical ventilation), paralysis or paraparesis, bowel ischemia requiring surgical intervention or procedural blood loss ≥ 1,000 cc.
Primary effectiveness endpoint: Successful aneurysm treatment
Time frame: Conclusion of the index procedure
Successful aneurysm treatment defined as the composite of 1. Technical success, defined as successful insertion of the delivery system through the vasculature, successful deployment of the device at the intended location, and successful removal of the delivery system 2. Immobilization of the distal AAA neck, defined as aortic circumferential cyclic strain < 10% as measured via vascular ultrasound at the conclusion of the index procedure and assessed by an independent core laboratory
9 secondary outcomes
Secondary safety endpoint: Absence of Major Adverse Events
Time frame: 180 days, 12 months,vand 24 months post index procedure.
Secondary safety endpoint: Procedure related complications
Time frame: 30 days, 6 months, 12 months, and 24 months post index procedure
Secondary safety endpoint: Device related complications
Time frame: 30 days, 6 months, 12 months, and 24 months post index procedure
Secondary effectiveness endpoint: Freedom of aneurysmal sac enlargement
Time frame: Day 30, 12 months, and 24 months post index procedure
Secondary effectiveness endpoint: Aneurysmal sac shrinkage
Time frame: Day 30, 12 months, and 24 months post index procedure
Secondary effectiveness endpoint: Technical Success
Time frame: Day 30
Secondary effectiveness endpoint: Immobilization of the distal AAA neck
Time frame: Day 30, 6 months, 12 months and 24 months
Secondary effectiveness endpoint: Absence of requirement of AAA repair
Time frame: 30 days, 6 months, 12 months, and 24 months post index procedure.
Secondary effectiveness endpoint: Absence of aneurysm related mortality
Time frame: 6 months, 12 months, and 24 months post index 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 Jan 2026.
- 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.
Uwe Raaz, MD study director
Angiolutions GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A3-Shield Implantation in people with Aneurysm, Abdominal Aortic, run by Angiolutions GmbH at 1 site in Uzbekistan.
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 30 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 Jan 2026. 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 Uzbekistan. 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 Uwe Raaz, MD (+49 (0) 511 9666938, uwe@angiolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint: Absence of Major Adverse Events (time frame: Within 30 days of the index 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 Jan 2026.