Abdominal Aortic AneurysmLEAFNCT06990048
The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
An observational study of Abdominal Aortic Aneurysm, run by Endologix at 1 site in United States.
Trial summary
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- AFX2 System
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to May 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately 20,000 patient data will be extracted from approximately 900 sites participating in the VQI EVAR registry in the US. A minimum of 2000 AFX2 System patients will be included.
Who may be able to join
- All patients implanted with the AFX2 System or the 3 most commonly used comparator devices who underwent EVAR as their first abdominal aortic aneurysm repair in the VQI EVAR registry will be included in this study.
Who cannot join
- Ruptured AAA repair with the AFX2 or comparator device
- Patients with AFX2 in AFX relining, or relined comparator grafts.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Dartmouth Institute
Lebanon, New Hampshire, 03756
About this study
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
Read the detailed description
Evaluate the clinical performance of the AFX2 System patients against other commercially available EVAR devices and evaluate the Type III endoleak occurrence in AFX2 System patients through 5 years.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- AFX2 System
- 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.
AFX2 SystemDevice
The AFX2 System comprises of the following:
AFX2 Bifurcated Endograft System and delivery system AFX Vela Proxmal Endograft System and delivery system AFX Stand Alone Endograft System and delivery system
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of AAA Rupture, Reintervention and Mortality
Rate of the composite of AAA rupture, aortic-related reintervention, and morality through 5 years.
Measured: 5 Years
Incidence of Endoleak
Cummulative incidence of Type III endoleaks at 5 years.
Measured: 5 Years
Secondary outcomes (1)
Long Term Safety
Rates of AAA rupture, aoritic-related reintervention, mortality, aneurysm related mortality, rate of imaging with CT, presence of untreated asymptomatic Type III endoleaks, occurrence of sac shrinkage, stability, and expansion >5mm in diameter, and limb occlusion at 10 years.
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start21 Sep 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fivos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990048
- Sponsor's protocol ID
- CP-0024
- Acronym
- LEAF
- Status last verified
- May 2026
- First submitted
- 12 May 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
- ClinicalTrials.gov ID
- NCT06990048
- Acronym / sponsor ID
- LEAF / CP-0024
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Collaborators
- Fivos
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 May 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.
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
Detailed description
Evaluate the clinical performance of the AFX2 System patients against other commercially available EVAR devices and evaluate the Type III endoleak occurrence in AFX2 System patients through 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 20,000 patient data will be extracted from approximately 900 sites participating in the VQI EVAR registry in the US. A minimum of 2000 AFX2 System patients will be included.
Key inclusion criteria (1 listed)
- All patients implanted with the AFX2 System or the 3 most commonly used comparator devices who underwent EVAR as their first abdominal aortic aneurysm repair in the VQI EVAR registry will be included in this study.
Key exclusion criteria (2 listed)
- Ruptured AAA repair with the AFX2 or comparator device
- Patients with AFX2 in AFX relining, or relined comparator grafts.
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 |
|---|---|---|
| AFX2 SystemThe AFX2 System comprises of the following: AFX2 Bifurcated Endograft System and delivery system AFX Vela Proxmal Endograft System and delivery system AFX Stand Alone Endograft System and delivery system | Device | – |
Primary outcome
Rates of AAA Rupture, Reintervention and Mortality
Time frame: 5 Years
Rate of the composite of AAA rupture, aortic-related reintervention, and morality through 5 years.
Incidence of Endoleak
Time frame: 5 Years
Cummulative incidence of Type III endoleaks at 5 years.
1 secondary outcome
Long Term Safety
Time frame: 10 Years
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 12 May 2026.
- Individual participant dataSharing planned: No
Related trials for Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
Abdominal Aortic Aneurysm, Endoleak
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Endologix at 1 site in United States.
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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 12 May 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of AAA Rupture, Reintervention and Mortality (time frame: 5 Years). 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 12 May 2026.