Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks (AAA-SHAPE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04227054 |
Recruitment Status :
Recruiting
First Posted : January 13, 2020
Last Update Posted : May 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Abdominal Aortic Aneurysm | Device: IMPEDE-FX Embolization Plug | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Single Center Safety Study |
Actual Study Start Date : | September 9, 2020 |
Estimated Primary Completion Date : | June 2023 |
Estimated Study Completion Date : | June 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention |
Device: IMPEDE-FX Embolization Plug
Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft |
- Incidence of related major adverse events (MAEs) [ Time Frame: 30 days post-procedure ]Incidence of related major adverse events (MAEs)
- Efficacy - Technical Success [ Time Frame: Immediately after the intervention ]Technical success, defined as filling of the residual flow lumen of the AAA sac with investigational products
- Incidence of related major adverse events (MAEs) [ Time Frame: 2 years post-procedure ]Incidence of related major adverse events (MAEs)
- Incidence of related serious adverse events (SAEs) [ Time Frame: 2 years post-procedure ]Incidence of related serious adverse events (SAEs)
- Efficacy - Type II endoleaks [ Time Frame: 2 years post-procedure ]Incidence of type II endoleaks
- Efficacy - Type I and type III endoleaks [ Time Frame: 2 years post-procedure ]Incidence of type I and type III endoleaks
- Efficacy - AAA sac diameter/volume [ Time Frame: 2 years post-procedure ]Change in AAA sac diameter/volume
- Efficacy - Open repair [ Time Frame: 2 years post-procedure ]Rate of conversion to open AAA repair
- Efficacy - Reinterventions [ Time Frame: 2 years post-procedure ]Rate of other reinterventions related to the AAA sac growth and/or complications

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥18 years of age
- A candidate for elective EVAR of an infrarenal aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women
Exclusion Criteria:
- An inability to provide informed consent
- Enrolled in another clinical study
- Concomitant iliac artery ectasia or aneurysm (common iliac artery diameter >24 mm)
- Patent AAA sac feeding vessels (within the sac) >4 mm in diameter
- Volume of AAA sac to be filled after stent graft placement <30 mL or >135 mL, based on pre-procedure CTA (i.e. aortic flow volume exclusive of stent graft volume)
- Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II Stent Graft, or Endologix Ovation Alto Abdominal Stent Graft System to treat the AAA
- Planned use of the chosen stent graft outside its instructions for use (IFU)
- Planned use of fenestrated or chimney stent grafts
- Study participants in which stent graft placement is abandoned for any reason, and/or in which the investigator decides, during the course of the stent graft placement, that the study procedure may not be appropriate
- Planned use of embolic devices other than the investigational product to embolize the AAA sac
- 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, or mycotic (infected) aneurysm
- Aneurysmal disease of the descending thoracic aorta
- Coagulopathy or uncontrolled bleeding disorder
- Long-term (>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin K antagonist anticoagulant use
- 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
- Unable or unwilling to comply with study follow-up requirements
- Life expectancy of <2 years post-procedure
- Known hypersensitivity or contraindication to platinum, iridium, or polyurethane
- A condition that inhibits radiographic visualization during the implantation procedure
- History of allergy to contrast medium that cannot be managed medically
- Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study
- Pregnant or a 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 study
- Prisoner or member of other vulnerable population.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227054
New Zealand | |
Auckland City Hospital | Recruiting |
Auckland, New Zealand, 1023 | |
Contact: Elleni Takele 09 307 4949 ext 21976 ElleniT@adhb.govt.nz | |
Principal Investigator: Andrew Holden, MB ChB | |
Waikato Hospital | Recruiting |
Hamilton, New Zealand, 3240 | |
Contact: Reenu Arora +64 7 8430105 reenu@clinicaltrialsnz.com | |
Principal Investigator: Manar Khashram, M.D. |
Responsible Party: | Shape Memory Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT04227054 |
Other Study ID Numbers: |
CRD1015 |
First Posted: | January 13, 2020 Key Record Dates |
Last Update Posted: | May 5, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Endoleak Vascular Diseases Cardiovascular Diseases |
Aortic Diseases Postoperative Hemorrhage Hemorrhage Pathologic Processes Postoperative Complications |