Aortic Aneurysm, AbdominalNCT06029660
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
A study testing IMPEDE-FX RapidFill Implants and EndoVascular Aneurysm Repair in people with Aortic Aneurysm, Abdominal, run by Shape Memory Medical, Inc. at 49 sites in 5 countries.
Trial summary
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- IMPEDE-FX RapidFill Implants and EndoVascular Aneurysm Repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 49 sitesin 5 countries
- Study dates
- 5 Apr 2024to Jul 2031
- 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
- ≥18 years of age
- A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;
- Thrombus burden (percentage of the AAA sac occupied by thrombus) <50%, based on pre-procedure CTA
- Maximum Lumen diameter within the AAA sac of ≥40mm.
- The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.
Who cannot join
- General
- An inability to provide informed consent.
- Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
- Unable or unwilling to comply with study follow-up requirements.
- Prisoner or member of other vulnerable population
- Anatomical
Show all 34Show fewer
- Concomitant iliac artery ectasia or aneurysm
- Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
- Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
- Connective tissue disorder (e.g., Marfan's syndrome)
- Aneurysmal disease of the descending thoracic aorta
- Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties
- EVAR/Procedural
- Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA
- Use of an aortic stent graft other than those specified1 for a particular site
- Planned use of the chosen stent graft outside its instructions for use (IFU)
- Use of fenestrated stent grafts or chimney techniques
- Use of the Heli-FX EndoAnchor system
- Use of embolic devices other than the investigational product to embolize the AAA sac
- Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries
- Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries
- Medical History/Conditions
- Coagulopathy or uncontrolled bleeding disorder
- Serum creatinine level >2.5 mg/dL
- Cerebrovascular accident within 3 months prior to the procedure
- Myocardial infarction and/or major heart surgery within 3 months prior to the procedure
- Atrial fibrillation that is not well rate controlled
- Life expectancy of <2 years post-procedure
- Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.
- Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC >11,000/mm3)
- A condition that inhibits radiographic visualization during the implantation procedure
- History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason.
- Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial
- Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial
Trial locations and contacts
49 sites in 5 countries.
49 sites in 5 countries
United States39 sites
VA Ann Arbor Healthcare
Ann Arbor, Michigan, 48105
Emory University Hospital
Atlanta, Georgia, 30322
St. David's Healthcare
Austin, Texas, 78705
Johns Hopkins
Baltimore, Maryland, 21205
University of Alabama Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University at Buffalo
Buffalo, New York, 14203
Buffalo VA Western New York
Buffalo, New York, 14215
University of Virginia
Charlottesville, Virginia, 22903
University of Chicago
Chicago, Illinois, 60637
TriHealth Heart Institute
Cincinnati, Ohio, 45242
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Delray Medical Center
Delray Beach, Florida, 33484
Inova Schar Heart and Vascular
Falls Church, Virginia, 22042
Corewell Health
Grand Rapids, Michigan, 49503
Houston Methodist
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC Keck
Los Angeles, California, 90033
University of Wisconsin
Madison, Wisconsin, 53715
Mt. Sinai Medical Center
Miami Beach, Florida, 33140
Vanderbilt University
Nashville, Tennessee, 37232
NYU Langone
New York, New York, 10016
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Sentara Norfolk General
Norfolk, Virginia, 23507
Orlando Health
Orlando, Florida, 32806
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Baylor Scott and White
Plano, Texas, 75093
Maine Medical
Portland, Maine, 04102
Mayo Clinic
Rochester, Minnesota, 55902
University of Rochester
Rochester, New York, 14642
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
San Diego VA Medical Center
San Diego, California, 92161
Honor Health
Scottsdale, Arizona, 85258
Sanford Health
Sioux Falls, South Dakota, 57105
Stony Brook Medicine
Stony Brook, New York, 11794
University of South Florida
Tampa, Florida, 33606
Netherlands4 sites
Amsterdam UMC
Amsterdam
Rijnstate Hospital
Arnhem, Gelderland, 6800 TA
Erasmus Medical Center
Rotterdam, 3015 GD
ETZ Elisabeth
Tilburg, Tilburg, 5022 GC
France2 sites
Hopital Cardiologie
Lille, Hauts-de-France, 59037
Marie Lannelongue Hospital
Paris, Le Plessis-Robinson, 92350,
New Zealand2 sites
Auckland City Hospital
Auckland, Auckland, 1023
Waikato Hospital
Hamilton, 3204
United Kingdom2 sites
St Georges University Hospitals NHS Foundation Trust
London, SW17 0GT
St. Marys Hospital
London, W21 1NY
About this study
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- IMPEDE-FX RapidFill Implants, EndoVascular Aneurysm Repair
- Keywords
- Abdominal Aortic Aneurysm
- 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.
IMPEDE-FX RapidFill ImplantsDevice
Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
EndoVascular Aneurysm RepairProcedure or surgery
Also called EVAR
Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted. Receives: Device: IMPEDE-FX RapidFill Implants; Procedure: EndoVascular Aneurysm Repair |
| Control | Active comparator | Control Arm: Subjects in the control arm will only have an EVAR device implanted. Receives: Procedure: EndoVascular Aneurysm Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.
Measured: 1 year
Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
Freedom from the following through 30 days post-index procedure:
- Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1000 mL.
- AAA-rupture or AAA-perforation
- Conversion to Open Repair
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start5 Apr 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Model description
- A prospective, multicenter, randomized, open-label trial.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shape Memory Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Marc Schermerhorn, M.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029660
- Sponsor's protocol ID
- CRD 1029
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2023
- Last updated
- 10 Jul 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
- ClinicalTrials.gov ID
- NCT06029660
- Acronym / sponsor ID
- CRD 1029
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shape Memory Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 8 Sep 2023 (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.
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, multicenter, randomized, open-label trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: IMPEDE-FX RapidFill Implants, Procedure: EndoVascular Aneurysm RepairTreatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted. |
| Control | Active comparator | Procedure: EndoVascular Aneurysm RepairControl Arm: Subjects in the control arm will only have an EVAR device implanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;
- Thrombus burden (percentage of the AAA sac occupied by thrombus) <50%, based on pre-procedure CTA
- Maximum Lumen diameter within the AAA sac of ≥40mm.
- The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.
Key exclusion criteria (34 listed)
- General
- An inability to provide informed consent.
- Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
- Unable or unwilling to comply with study follow-up requirements.
- Prisoner or member of other vulnerable population
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 |
|---|---|---|
| IMPEDE-FX RapidFill ImplantsFilling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants | Device | Treatment |
| EndoVascular Aneurysm RepairAlso: EVARStandard EVAR repair of abdominal aortic aneurysms using a commercially available stent. | Procedure or surgery | Control, Treatment |
Primary outcome
Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
Time frame: 1 year
The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.
Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
Time frame: 30 days
Freedom from the following through 30 days post-index procedure: * Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1000 mL. * AAA-rupture or AAA-perforation * Conversion to Open Repair
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 10 Jul 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. This study is not recruiting at the moment.
Marc Schermerhorn, M.D. principal investigator
Beth Israel Deaconess Medical Center
49 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPEDE-FX RapidFill Implants and EndoVascular Aneurysm Repair in people with Aortic Aneurysm, Abdominal, run by Shape Memory Medical, Inc. at 49 sites in 5 countries.
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 5 inclusion and 34 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 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Netherlands, France, New Zealand, United Kingdom. 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?
Primary Effectiveness Endpoint : AAA Sac Regression at 1 year (time frame: 1 year). 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 10 Jul 2026.