Abdominal Aortic AneurysmLEOPARDNCT02407457
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
A study testing AFX EVAR AAA Graft System and FDA Approved EVAR AAA Graft Systems in people with Abdominal Aortic Aneurysm, run by Endologix at 56 sites in United States.
Trial summary
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. 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?
- AFX EVAR AAA Graft System and FDA Approved EVAR AAA Graft Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 56 sitesUnited States
- Study dates
- Mar 2015to Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female at least 18 years old
- Subjects with minimum of 2 year life expectancy
- Subjects have signed the informed consent document for data release
- Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
Who cannot join
- Currently participating in another study where primary endpoint has not been reached yet
- Known allergy to any of the device components
- Pregnant (females of childbearing potential only)
- Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
The Vascular Group
Albany, New York, 12208
Emory/Grady
Atlanta, Georgia, 30303
Cardiothoracic & Vascular Surgeons
Austin, Texas, 78756
VA Maryland Health Care System
Baltimore, Maryland, 21201
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, 70808
Baton Rouge Vascular Specialty Center
Baton Rouge, Louisiana, 70809
Massachusetts General Hospital
Boston, Massachusetts, 02114
VA Western New York Healthcare System
Buffalo, New York, 14215
University of Vermont Medical Center
Burlington, Vermont, 05401
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Penrose St. Francis Health
Colorado Springs, Colorado, 80907
University of Missouri
Columbia, Missouri, 65212
Geisinger Medical Center
Danville, Pennsylvania, 17822
Eliza Coffee Medical Center
Florence, Alabama, 35630
Parkview Research Center
Fort Wayne, Indiana, 46845
Hattiesburg Clinic
Hattiesburg, Mississippi, 39402
University of Texas Health
Houston, Texas, 77030
Huntsville Hospital
Huntsville, Alabama, 35801
Franciscan - St. Francis Hospital
Indianapolis, Indiana, 46237
University of Iowa Healthcare
Iowa City, Iowa, 52246
Mayo Jacksonville
Jacksonville, Florida, 32224
Innovation Center, Kettering Health Network
Kettering, Ohio, 45429
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, 72205
Long Beach VA Hospital
Long Beach, California, 90822
Surgical Care Associates
Louisville, Kentucky, 40207
Navicent Health Medical Center
Macon, Georgia, 31201
University of Wisconsin
Madison, Wisconsin, 53792
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, 53295
Hartford Hospital
New Britain, Connecticut, 61110
Yale University
New Haven, Connecticut, 48097
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Kansas City Vascular
North Kansas City, Missouri, 64116
Vascular Institute of Central Florida
Orlando, Florida, 32803
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Banner Good Samaritan Hospital
Phoenix, Arizona, 85006
Sacramento Vascular Sugeons
Sacramento, California, 95816
Peninsula Regional Medical Center
Salisbury, Maryland, 21801
Kaiser - Santa Clara
Santa Clara, California, 95051
Sarasota Vascular Specialists
Sarasota, Florida, 34232
North Central Heart
Sioux Falls, South Dakota, 57108
Prairie Education & Research Cooperative
Springfield, Illinois, 62701
Saint Louis University
St Louis, Missouri, 63124
Peachtree Vascular Specialists
Stockbridge, Georgia, 30281
USF/Tampa VA
Tampa, Florida, 33606
Carondelet Heart and Vascular Institute
Tucson, Arizona, 85745
North MS Medical Center
Tupelo, Mississippi, 38801
Peacehealth Southwest Medical Center
Vancouver, Washington, 98664
The Iowa Clinic Cardiovascular Services
West Des Moines, Iowa, 50266
Neo Vascular (Lake West)
Willoughby, Ohio, 44094
Cadence Physician Group
Winfield, Illinois, 60190
Wake Forest
Winston-Salem, North Carolina, 27157
St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
About this study
Official title: Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.
Read the detailed description
This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups.
Randomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses.
Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- AFX EVAR AAA Graft System, FDA Approved EVAR AAA Graft Systems
- 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.
AFX EVAR AAA Graft SystemDevice
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
FDA Approved EVAR AAA Graft SystemsDevice
| Study group | Role | What they receive |
|---|---|---|
| AFX EVAR AAA Graft System | Active comparator | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. Receives: Device: AFX EVAR AAA Graft System |
| FDA Approved EVAR AAA Graft Systems | Active comparator | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. Receives: Device: FDA Approved EVAR AAA Graft Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Absence of Aneurysm Related Complications (ARC)
ARC is a composite of the most relevant EVAR outcomes and includes:
- Peri-Operative Death (< 30 days)
- Rupture
- Conversion to OSR
- Endoleaks; post-operative
- Migration (≥ 10mm)
- Aneurysm Enlargement (≥ 5mm)
- Endograft Limb Occlusions
- Reinterventions for device- or aneurysm-related complications
Measured: 1 year
Secondary outcomes (14)
The Number of MAEs
Major Adverse Events
Measured: At 30 days, 12 months, and annually up to five years
The Number of Participants With Aneurysm Related Complications (ARC)
ARC is a composite outcome
Measured: Post 12 Months up to Five Years
The Number of Participants With Aneurysm Related Mortality
Death related to the aneurysm
Measured: Up to Five Years
Number of Type Ia Endoleaks
Number of participants with Type Ia endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ia endoleak defined as persistent leak around the top of the stent graft identified during imaging surveillance at the different timepoints.
Measured: Up to Five Years
Number of Type Ib Endoleaks
Number of participants with Type Ib endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ib endoleak defined as persistent leak around the bottom of the stent graft identified during imaging surveillance at the different timepoints.
Measured: Up to Five Years
Number Endoleaks Type II
Number of participants with Type II endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type II endoleak defined as persistent blood flow into the aneurysm sac from branches of the aorta identified during imaging surveillance at the different timepoints.
Measured: Up to Five Years
Number of Endoleaks Type IIIa
Number of participants with Type IIIa endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIa endoleak defined as persistent leak from the overlapping parts of the stent graft identified during imaging surveillance at the different timepoints.
Measured: Up to Five Years
Number of Endoleaks Type IIIb
Number of participants with Type IIIb endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIb endoleak defined as persistent leak as a consequence of graft rupture, identified during imaging surveillance at the different timepoints.
Measured: Up to Five Years
Number of Participants With Aneurysm Rupture
Number of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Measured: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Participants With Open Conversion
Number of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Measured: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Participants With Aneurysm Expansion
Number of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months
Measured: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Patients With Endograft Occlusion
Number of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Measured: 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Number of Participants With Device-Related Secondary Interventions
Number of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Measured: 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Patients With Adjunctive Procedures
Number of patients with adjunctive procedure during the implant
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2018
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Kwolek, MD, Principal investigator, Endologix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407457
- Sponsor's protocol ID
- CP-0011
- Acronym
- LEOPARD
- Status last verified
- Sep 2024
- First submitted
- 6 Mar 2015
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607-18. doi: 10.1056/NEJMoa042002.
PubMed 15483279Volodos' NL, Karpovich IP, Shekhanin VE, Troian VI, Iakovenko LF. [A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm]. Grudn Khir. 1988 Nov-Dec;(6):84-6. No abstract available. Russian.
PubMed 3220297Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.
PubMed 15351191Brown LC, Greenhalgh RM, Thompson SG, Powell JT; EVAR Trial Participants. Does EVAR alter the rate of cardiovascular events in patients with abdominal aortic aneurysm considered unfit for open repair? Results from the randomised EVAR trial 2. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):396-402. doi: 10.1016/j.ejvs.2010.01.002. Epub 2010 Jan 21.
PubMed 20096611Stroupe KT, Lederle FA, Matsumura JS, Kyriakides TC, Jonk YC, Ge L, Freischlag JA; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial. J Vasc Surg. 2012 Oct;56(4):901-9.e2. doi: 10.1016/j.jvs.2012.01.086. Epub 2012 May 27.
PubMed 22640466De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.
PubMed 20484396Kwolek CJ, Ouriel K, Stucky FS, Rao VK, Pons PJ, Wilson SE, Kujath SW. Five-year results of the LEOPARD trial of commercially available endografts. J Vasc Surg. 2023 Aug;78(2):324-332.e2. doi: 10.1016/j.jvs.2023.04.011. Epub 2023 Apr 15.
PubMed 37068528
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
- ClinicalTrials.gov ID
- NCT02407457
- Acronym / sponsor ID
- LEOPARD / CP-0011
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Posted 21 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.
Detailed description
This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups.
Randomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses.
Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFX EVAR AAA Graft System | Active comparator | Device: AFX EVAR AAA Graft SystemSubjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. |
| FDA Approved EVAR AAA Graft Systems | Active comparator | Device: FDA Approved EVAR AAA Graft SystemsSubjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female at least 18 years old
- Subjects with minimum of 2 year life expectancy
- Subjects have signed the informed consent document for data release
- Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
Key exclusion criteria (4 listed)
- Currently participating in another study where primary endpoint has not been reached yet
- Known allergy to any of the device components
- Pregnant (females of childbearing potential only)
- Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR
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 |
|---|---|---|
| AFX EVAR AAA Graft SystemEndvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | Device | AFX EVAR AAA Graft System |
| FDA Approved EVAR AAA Graft Systems | Device | FDA Approved EVAR AAA Graft Systems |
Primary outcome
Number of Patients With Absence of Aneurysm Related Complications (ARC)
Time frame: 1 year
ARC is a composite of the most relevant EVAR outcomes and includes: * Peri-Operative Death (< 30 days) * Rupture * Conversion to OSR * Endoleaks; post-operative * Migration (≥ 10mm) * Aneurysm Enlargement (≥ 5mm) * Endograft Limb Occlusions * Reinterventions for device- or aneurysm-related complications
14 secondary outcomes
The Number of MAEs
Time frame: At 30 days, 12 months, and annually up to five years
The Number of Participants With Aneurysm Related Complications (ARC)
Time frame: Post 12 Months up to Five Years
The Number of Participants With Aneurysm Related Mortality
Time frame: Up to Five Years
Number of Type Ia Endoleaks
Time frame: Up to Five Years
Number of Type Ib Endoleaks
Time frame: Up to Five Years
Number Endoleaks Type II
Time frame: Up to Five Years
Number of Endoleaks Type IIIa
Time frame: Up to Five Years
Number of Endoleaks Type IIIb
Time frame: Up to Five Years
Number of Participants With Aneurysm Rupture
Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Participants With Open Conversion
Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Participants With Aneurysm Expansion
Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Patients With Endograft Occlusion
Time frame: 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Number of Participants With Device-Related Secondary Interventions
Time frame: 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Patients With Adjunctive Procedures
Time frame: Intraprocedural
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15483279Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607-18. doi: 10.1056/NEJMoa042002.
- Background: PubMed 3220297Volodos' NL, Karpovich IP, Shekhanin VE, Troian VI, Iakovenko LF. [A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm]. Grudn Khir. 1988 Nov-Dec;(6):84-6. No abstract available. Russian.
- Background: PubMed 15351191Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.
- Background: PubMed 20096611Brown LC, Greenhalgh RM, Thompson SG, Powell JT; EVAR Trial Participants. Does EVAR alter the rate of cardiovascular events in patients with abdominal aortic aneurysm considered unfit for open repair? Results from the randomised EVAR trial 2. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):396-402. doi: 10.1016/j.ejvs.2010.01.002. Epub 2010 Jan 21.
- Background: PubMed 22640466Stroupe KT, Lederle FA, Matsumura JS, Kyriakides TC, Jonk YC, Ge L, Freischlag JA; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial. J Vasc Surg. 2012 Oct;56(4):901-9.e2. doi: 10.1016/j.jvs.2012.01.086. Epub 2012 May 27.
- Background: PubMed 20484396De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.
- Derived from this study: PubMed 37068528Kwolek CJ, Ouriel K, Stucky FS, Rao VK, Pons PJ, Wilson SE, Kujath SW. Five-year results of the LEOPARD trial of commercially available endografts. J Vasc Surg. 2023 Aug;78(2):324-332.e2. doi: 10.1016/j.jvs.2023.04.011. Epub 2023 Apr 15.
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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. This study is not recruiting at the moment.
Christopher Kwolek, MD principal investigator
Endologix
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFX EVAR AAA Graft System and FDA Approved EVAR AAA Graft Systems in people with Abdominal Aortic Aneurysm, run by Endologix at 56 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites 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?
Yes. Results are posted in the registry (first posted 21 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Absence of Aneurysm Related Complications (ARC) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407457, which also lists 7 linked publications.
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 1 Oct 2024.