IMPEDE-FX + Stent Graft for Abdominal Aortic Aneurysm
Recruiting in Palo Alto (17 mi)
+26 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Shape Memory Medical, Inc.
Disqualifiers: Connective tissue disorder, Coagulopathy, others
Stay on Your Current Meds
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment IMPEDE-FX RapidFill Implants and Device for Abdominal Aortic Aneurysm?
The research highlights that newer generations of endoluminal grafts, like the ones used in the IMPEDE-FX treatment, have shown reduced rates of complications such as leaks and blockages, indicating potential effectiveness in treating abdominal aortic aneurysms.
12345Is the IMPEDE-FX + Stent Graft treatment for Abdominal Aortic Aneurysm safe?
The research on stent grafts for abdominal aortic aneurysm repair shows that they are generally safe, with low rates of complications like renal infarctions (3.0%) and limb occlusion (2.7%). However, there can be specific complications during the procedure, and long-term safety data is limited.
26789How does the IMPEDE-FX + Stent Graft treatment for abdominal aortic aneurysm differ from other treatments?
The IMPEDE-FX + Stent Graft treatment is unique because it combines a stent graft with a novel embolization device, potentially offering enhanced stability and reduced risk of complications compared to traditional stent grafts alone. This approach may improve outcomes by providing better sealing and support within the aneurysm.
47101112Eligibility Criteria
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 18 years old or older.
I am eligible for a specific surgery to treat my large aortic aneurysm.
My abdominal aorta is enlarged to 40mm or more.
+2 more
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.
+26 more
Trial Timeline
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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment2 Interventions
Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
Group II: ControlActive Control1 Intervention
Control Arm: Subjects in the control arm will only have an EVAR device implanted.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Honor HealthScottsdale, AZ
Sentara Norfolk GeneralNorfolk, VA
NYU LangoneNew York, NY
Ohio State University Wexner Medical CenterColumbus, OH
More Trial Locations
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Who Is Running the Clinical Trial?
Shape Memory Medical, Inc.Lead Sponsor
NAMSACollaborator
References
Repair of abdominal aortic aneurysm by transfemoral endovascular graft placement. [2019]The authors describe the initial clinical experience with a new device, approved by the FDA for investigation, for repair of abdominal aortic aneurysm by transfemoral endovascular insertion of an aortic graft.
Troubleshooting techniques for abdominal aortic aneurysm endograft placement: when things go wrong. [2022]Since the Food and Drug Administration approved the Ancure (Guidant Corp, Menlo Park, CA) and AneuRx (Medtronic Corp, Minneapolis, MN) abdominal aortic aneurysm stent-grafts, there has been a tremendous increase in the number of stent-graft implantations, both in the United States and worldwide. Successful stent-graft deployment requires complex interventional skills and accurate preprocedure planning. Even the most skilled operator may experience intraoperative difficulties during graft deployment. There are intraprocedural complications that are common to all stent-grafts, as well as specific complications that are unique to the particular stent-graft being implanted. The first step to managing an intraprocedural complication is to be able to quickly recognize that a deployment difficulty has occurred. The interventionalist must then be ready to use common troubleshooting techniques to rectify or avoid complications of stent-graft delivery.
Late abdominal aortic aneurysm rupture after AneuRx repair: a report of three cases. [2012]Rupture due to device failure and/or endoleak is the most feared complication of endoluminal grafting for exclusion of abdominal aortic aneurysm. We present three previously unreported cases of abdominal aortic aneurysm rupture 23 months after AneuRx "repair" and describe the mechanisms of failure and discuss instructive technical aspects of their management.
Current status of endoluminal grafting for exclusion of abdominal aortic aneurysms. The beauty and the beast. [2018]The exclusion of abdominal aortic aneurysms with endoluminal grafts has generated a great deal of interest since the early 1990s, and many centers are currently evaluating the procedure and comparing it to classic surgical exclusion. Although endoluminal grafting procedures show promise, development and clinical testing of devices is a time-consuming process that is influenced greatly by the regulatory climate in the country where the clinical trials take place. Nevertheless, a number of devices are currently under study, and the advantages of 2nd- and 3rd-generation technology are reflected in reduced rates of complications such as endoleaks and thrombosis. Further study will be required to perfect these devices and observe their long-term success in the exclusion of abdominal aortic aneurysms.
Endovascular placement of a nitinol-ePTFE stent-graft for abdominal aortic aneurysms: initial and midterm results. [2019]Because first-generation stent-grafts did not meet initial expectations, a recently designed nitinol-expanded polytetrafluoroethylene (ePTFE) stent-graft was tested for treatment of abdominal aortic aneurysms (AAAs) in a prospective clinical study. The primary study endpoints were technical success and safety.
Risk-adjusted outcome analysis of endovascular abdominal aortic aneurysm repair in a large population: how do stent-grafts compare? [2016]To compare differences in the applicability and incidence of postoperative adverse events among stent-grafts used for repair of infrarenal aortic aneurysms.
[Experiences and results with the Endologix-bifurcated endovascular graft]. [2016]Since the first endograft implantation for treatment of abdominal aneurysms the development of modern stentgrafts has progressed in many ways. In 1999 we started implantations using the PowerLink aortic stent graft by Endologix-company. The PowerLink aortic stent graft is a bifurcated, self-expanding, sutureless endovascular graft, covered with PTFE. This aortic stent graft facilitates the complete covering of the infrarenal aorta and the iliac arteries. The anatomical localization at the natural aortic bifurcation provides anti-gravitational supporting force, preventing distal migration of the device. From 1999 to 2005 we implanted 297 PowerLink aortic stent grafts. Our follow-up examinations showed a low rate of renal infarctions (3.0 %), a limb occlusion rate of 2.7 % and a total endoleakage rate of 16.8 %. Our conclusion is, that this is a very safe device for repair of abdominal aneurysms, associated with a low-risk of complications.
Indications and outcomes of AneuRx Phase III trial versus use of commercial AneuRx stent graft. [2012]Approval by the United States Food and Drug Administration of endoluminal repair of abdominal aortic aneurysm (AAA) with the AneuRx stent graft was based on the outcome of a multicenter trial in which patients met strict inclusion and exclusion criteria. Since widespread use of the commercially available graft, little information is available as to whether indications and outcomes have evolved. We examined this important issue at our institution.
Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study. [2023]Concerns have been raised about the long-term performance of aortic stent grafts for the treatment of abdominal aortic aneurysms, in particular, unibody stent grafts (eg, Endologix AFX AAA stent grafts). Only limited data sets are available to evaluate the long-term risks related to these devices. The SAFE-AAA Study (Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries Study) was designed with the Food and Drug Administration to provide a longitudinal assessment of the safety of unibody aortic stent grafts among Medicare beneficiaries.
[First experience with the Anaconda modular endovascular stent graft used for treatment of infrarenal aortic aneurysms]. [2016]Described herein is a favourable outcome following endovascular repair of an infrarenal abdominal aortic aneurysm using the Anaconda modular stent-graft system (manufactured by the Vascutek Co., Ltd.). The device employed and the technique pertaining thereto have proved both safe and effective in terms of good clinical outcomes obtained in the immediate and early longer-term postoperative periods.
The Bolton Treovance endograft: single center experience. [2022]In the last two decades, results of endovascular aortic repair (EVAR) for the treatment of infrarenal abdominal aortic aneurysms (AAAs) have significantly improved thanks to the evolution of stent-grafts and endovascular delivery systems. However, further development is still needed to reduce the incidence of complications and secondary reinterventions. We present our initial experience with the Treovance abdominal aortic stent-graft (Bolton Medical, Barcelona, Spain), a new-generation trimodular endovascular device, developed to increase flexibility, lower profile, improve deployment and sealing mechanisms.
Tips to Ensure Optimal Ring Apposition of the Ovation Stent Graft in Challenging Necks of Abdominal Aortic Aneurysms. [2020]The Ovation stent graft has been recently introduced for endovascular repair of abdominal aortic aneurysms. Its sealing mechanism is based on a pair of polymer-filled inflatable rings. Based on our experience, we describe useful tips to optimize the use of Ovation in thrombosed or severely angulated necks.