IMPEDE-FX + Stent Graft for Abdominal Aortic Aneurysm

Recruiting at 40 trial locations

Overseen By Peter Miller, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shape Memory Medical, Inc.

Disqualifiers: Connective tissue disorder, Coagulopathy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether adding IMPEDE-FX RapidFill implants during standard endovascular repair can shrink abdominal aortic aneurysms (a swollen blood vessel in the belly) more safely and effectively. The trial includes two groups: one receives the implants with the standard treatment, while the other receives only the standard treatment. It suits individuals who require a planned repair for their abdominal aortic aneurysm and meet specific size and condition criteria. As an unphased trial, it allows participants to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the IMPEDE-FX RapidFill Device is safe for use in abdominal aortic aneurysm treatment?

Research is exploring how IMPEDE-FX RapidFill implants might treat abdominal aortic aneurysms, which are bulging areas in the aorta. Specific safety information from these studies is not yet available, but the trial's "Not Applicable" phase designation suggests early testing stages. Detailed safety data is still being collected. However, the FDA has granted an Investigational Device Exemption (IDE) approval, indicating some level of safety, as the device must meet certain standards for testing in people. Additionally, the device's unique features may potentially improve treatment outcomes, which is encouraging. Participants should stay informed and discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about IMPEDE-FX RapidFill implants for abdominal aortic aneurysms because they offer a novel approach to enhancing the effectiveness of Endovascular Aneurysm Repair (EVAR) devices. Unlike standard EVAR treatments that solely use a stent graft to support the weakened artery, IMPEDE-FX introduces an additional layer of protection by filling the aneurysm sac with specially designed implants. This can potentially reduce the risk of aneurysm growth or rupture by providing a more robust seal and promoting clot formation within the aneurysm. By combining the structural support of a stent graft with the innovative sealing of the IMPEDE-FX implants, this treatment could improve patient outcomes and longevity.

What evidence suggests that the IMPEDE-FX RapidFill Device is effective for abdominal aortic aneurysm?

Research has shown that IMPEDE-FX RapidFill Implants can help reduce the size of an abdominal aortic aneurysm (AAA) sac. In this trial, participants in the treatment arm will receive both an EVAR device and IMPEDE-FX RapidFill implants. One study found that using this device during endovascular aneurysm repair (EVAR) led to a noticeable decrease in the aneurysm sac size after one year. The treatment demonstrated promising results in improving patient outcomes and proved safe to use. This suggests that IMPEDE-FX RapidFill could be a valuable addition to the standard EVAR procedure for better shrinking of the aneurysm sac. ^{1 2 3 6 7}

Who Is on the Research Team?

Marc L Schermerhorn, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific type of swelling in the main artery of their abdomen (abdominal aortic aneurysm) that's at least 5.5 cm wide in men or 5.0 cm in women, suitable for elective stent graft treatment, and have less than half of the aneurysm filled with blood clot.

Inclusion Criteria

I am eligible for a specific surgery to treat my large aortic aneurysm.

My abdominal aorta is enlarged to 40mm or more.

The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200

Exclusion Criteria

Planned use of the chosen stent graft outside its instructions for use (IFU)

Connective tissue disorder (e.g., Marfan's syndrome)

I cannot or do not want to follow the study's follow-up rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted, while control arm subjects will only have an EVAR device implanted.

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for major adverse events through 30 days post-index procedure and for AAA sac regression at 1 year.

1 year

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• IMPEDE-FX RapidFill Implants

Trial Overview The trial tests if adding IMPEDE-FX RapidFill Implants to standard stent grafts can help shrink the size of the abdominal aortic aneurysm more effectively than just using stent grafts alone during elective repair surgery.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 2 Interventions

Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.

Group II: Control Active Control 1 Intervention

Control Arm: Subjects in the control arm will only have an EVAR device implanted.

Who Is Running the Clinical Trial?

Shape Memory Medical, Inc.

Lead Sponsor

Trials

7

Recruited

380+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Published Research Related to This Trial

In a study involving 10 patients with abdominal aortic aneurysms, 8 successfully received an endovascular graft through a transfemoral approach, demonstrating the procedure's safety and effectiveness.

Follow-up results showed that 6 out of 8 patients had normal function with complete aneurysm thrombosis, while 2 had incomplete thrombosis but no further expansion, indicating promising outcomes for this new device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair of abdominal aortic aneurysm by transfemoral endovascular graft placement. Moore, WS., Vescera, CL.[2019]

The approval of Ancure and AneuRx stent-grafts has led to a significant increase in their use for treating abdominal aortic aneurysms, highlighting their growing importance in medical practice.

Successful deployment of these stent-grafts requires advanced skills and careful planning, as operators may face common and specific complications during the procedure, necessitating quick recognition and effective troubleshooting strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Troubleshooting techniques for abdominal aortic aneurysm endograft placement: when things go wrong. Fox, LA., Powell, A.[2022]

In a comparison of two patient groups, those treated with the AneuRx graft after its commercial release had smaller abdominal aortic aneurysms and shorter aortic neck lengths than those in the original clinical trial, indicating a shift in patient characteristics over time.

Despite these differences in anatomy, both groups showed similar outcomes in terms of complications like endoleaks and the need for further interventions, suggesting that the AneuRx graft remains effective across different patient profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications and outcomes of AneuRx Phase III trial versus use of commercial AneuRx stent graft. Ayerdi, J., McLafferty, RB., Markwell, SJ., et al.[2012]

Three cases of abdominal aortic aneurysm rupture occurred 23 months after AneuRx endoluminal grafting, highlighting a significant risk of late complications associated with this device.

The study discusses the mechanisms of failure leading to these ruptures and provides important technical insights for managing such complications, emphasizing the need for careful monitoring after graft placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late abdominal aortic aneurysm rupture after AneuRx repair: a report of three cases. Politz, JK., Newman, VS., Stewart, MT.[2012]

The Ovation stent graft is a new device designed for the endovascular repair of abdominal aortic aneurysms, utilizing a unique sealing mechanism with polymer-filled inflatable rings.

The authors provide practical tips for effectively using the Ovation stent graft in challenging anatomical situations, such as thrombosed or severely angulated necks, based on their clinical experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tips to Ensure Optimal Ring Apposition of the Ovation Stent Graft in Challenging Necks of Abdominal Aortic Aneurysms. Georgakarakos, E., Koutsoumpelis, A., Tasopoulou, KM., et al.[2020]

Endoluminal grafting procedures for excluding abdominal aortic aneurysms show promise, particularly with advancements in 2nd- and 3rd-generation technologies that have reduced complications like endoleaks and thrombosis.

Despite the potential benefits, the development and clinical testing of these devices are lengthy processes influenced by regulatory environments, indicating that further research is needed to ensure their long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of endoluminal grafting for exclusion of abdominal aortic aneurysms. The beauty and the beast. Diethrich, EB.[2018]

The PowerLink aortic stent graft, used since 1999 for treating abdominal aneurysms, has shown a low complication rate with only 3.0% renal infarctions and 2.7% limb occlusions among 297 implants.

The total endoleakage rate was 16.8%, indicating that while the device is generally safe, there is a notable risk of endoleaks, which are important to monitor during follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experiences and results with the Endologix-bifurcated endovascular graft]. Hetzel, G., Raithel, D.[2016]

In a study of 6787 patients, different stent-grafts for repairing infrarenal aortic aneurysms showed significant differences in postoperative complications, with AneuRx, Excluder, Talent, and Zenith devices having lower risks of migration, kinking, and occlusion compared to the Vanguard device.

While some devices like AneuRx and Zenith reduced the risk of aneurysm rupture and all-cause mortality, no single stent-graft emerged as the best option, highlighting the need for continued development of improved devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-adjusted outcome analysis of endovascular abdominal aortic aneurysm repair in a large population: how do stent-grafts compare? van Marrewijk, CJ., Leurs, LJ., Vallabhaneni, SR., et al.[2016]

The SAFE-AAA Study found that unibody aortic stent grafts were not noninferior to non-unibody stent grafts in terms of aortic reintervention, rupture, and mortality, with 73.4% of unibody patients experiencing the primary endpoint compared to 65.0% of non-unibody patients over a median follow-up of 3.4 years.

The results indicate a need for ongoing monitoring of the safety of aortic stent grafts, as the contemporary unibody grafts did not show significant improvement in outcomes compared to non-unibody grafts, highlighting potential long-term risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study. Secemsky, EA., Song, Y., Sun, T., et al.[2023]

The Anaconda modular stent-graft system was successfully used for endovascular repair of an infrarenal abdominal aortic aneurysm, demonstrating both safety and effectiveness.

Patients experienced good clinical outcomes in both the immediate and early longer-term postoperative periods, indicating the reliability of this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[First experience with the Anaconda modular endovascular stent graft used for treatment of infrarenal aortic aneurysms]. Khabazov, RI., Troitskiĭ, AV., Beliakov, GA.[2016]

The nitinol-expanded polytetrafluoroethylene (ePTFE) stent-graft demonstrated a high technical success rate of 97% in accurately placing the device in 72 patients with abdominal aortic aneurysms (AAAs).

The stent-graft effectively excluded the aneurysm from arterial flow in 79.2% of patients, with a low complication rate of 4.1%, indicating it is a safe and effective treatment option for AAAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular placement of a nitinol-ePTFE stent-graft for abdominal aortic aneurysms: initial and midterm results. Cartes-Zumelzu, F., Lammer, J., Hoelzenbein, T., et al.[2019]

In a study involving 8 patients with non-ruptured abdominal aortic aneurysms, the Treovance stent-graft achieved primary technical success in all cases, with no device-related complications or deaths within the first 30 days.

At the 1-year follow-up for 6 patients, there were no observed device-related complications or endoleaks, indicating promising short-term efficacy and safety of this new-generation stent-graft, even in challenging anatomical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Bolton Treovance endograft: single center experience. Kahlberg, A., Mascia, D., Marone, EM., et al.[2022]

Citations

1. evtoday.com evtoday.com/news/shape-memory-medical-marks-50-enrollment-in-aaa-shape-pivotal-trial?c4src=news

Shape Memory Medical Marks 50% Enrollment in AAA ... “The IMPEDE-FX RapidFill's unique properties may offer meaningful advantages in improving post-EVAR outcomes.” AAA-SHAPE—Abdominal Aortic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06029660

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac ... To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0741521424000016

One-year follow-up after active aortic aneurysm sac ... Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile.

4. shapemem.com shapemem.com/shape_memory_medical_receives_fda_ide_approval/

Shape Memory Medical Receives FDA IDE Approval A prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12140958/

Quantifying the effect of IMPEDE-FX packing rate and ... This study aimed to quantify the nonbiologic effects of Shape Memory IMPEDE-FX embolization plug deployment rate and packing volume on pressure-normalized wall ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20577702

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac ... To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic ...

7. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06029660

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac ... To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac ...