Stent Graft Systems for Abdominal Aortic Aneurysm
(ADVANCE Trial)
Recruiting in Palo Alto (17 mi)
+61 other locations
Overseen byHence Verhagen, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medtronic Cardiovascular
Must not be taking: Anticoagulants, Anti-platelets
Disqualifiers: Life expectancy ≤ 3 years, Connective tissue disease, Prior aortic surgery, eGFR < 45, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, this may affect your eligibility.
What data supports the effectiveness of the treatment for abdominal aortic aneurysm?
Research shows that the Endurant and Excluder stent grafts are effective for treating abdominal aortic aneurysms, with studies reporting positive long-term outcomes and improvements in device performance, especially in challenging anatomical situations.
12345Is the Endurant Stent Graft System safe for treating abdominal aortic aneurysms?
The Endurant Stent Graft System has been shown to be safe for treating abdominal aortic aneurysms, with studies reporting good short-term and mid-term results. However, long-term safety data is still limited.
12678How does the Endurant and Excluder stent graft treatment for abdominal aortic aneurysm differ from other treatments?
The Endurant and Excluder stent grafts are designed to treat abdominal aortic aneurysms, especially in patients with challenging anatomies, by offering features like active fixation and improved flexibility. These stent grafts allow for a broader range of anatomical eligibility and have shown good short-term and mid-term results, although long-term data is still limited.
12689Eligibility Criteria
This trial is for adults with abdominal aortic aneurysms large enough to require intervention, who can commit to follow-up visits. They must be suitable for both Medtronic Endurant and Gore Excluder stent graft systems. Those with connective tissue diseases, life expectancy under 3 years, severe kidney issues, or certain psychiatric conditions cannot join.Inclusion Criteria
Your aortic aneurysm (AAA) fits the requirements for both the Medtronic Endurant II/IIs Stent Graft System and the Gore Excluder/Excluder Conformable AAA Endoprosthesis, as determined by your doctor and a specialized lab.
My aneurysm is at least 5 cm wide if I am a woman, or 5.5 cm if I am a man.
Subject and the treating physician agree that the subject will return for all required follow-up visits
+1 more
Exclusion Criteria
I need immediate treatment for a ruptured aneurysm.
My treatment includes covering the internal iliac artery.
You are not planning to have any additional devices inserted during the main procedure, such as staples, stents, or embolization devices.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo an EVAR procedure with either a Medtronic Endurant II/IIs Stent Graft System or Gore Excluder/Excluder Conformable AAA Endoprosthesis
Procedure day
1 visit (in-person)
Follow-up
Participants are monitored for sac regression and other outcomes with imaging collected at discharge, 30 days, and annually until 5 years
5 years
Multiple visits (in-person) at discharge, 30 days, annually
Participant Groups
The ADVANCE Trial compares the performance of two stent graft systems—Medtronic Endurant and Gore Excluder—in treating abdominal aortic aneurysms. Participants are randomly assigned one of the treatments and monitored through imaging to assess outcomes.
2Treatment groups
Experimental Treatment
Group I: Medtronic Endurant II/IIsExperimental Treatment1 Intervention
Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.
Group II: Gore Excluder / Excluder ConformableExperimental Treatment1 Intervention
Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.
Endurant Stent Graft System is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Endurant Stent Graft System for:
- Abdominal Aortic Aneurysms
🇺🇸 Approved in United States as Endurant Stent Graft System for:
- Abdominal Aortic Aneurysms
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale Center for Clinical InvestigationNew Haven, CT
University of Pittsburgh Medical CenterPittsburgh, PA
VA Maryland Health Care SystemBaltimore, MD
Northshore University Health SystemSkokie, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Medtronic CardiovascularLead Sponsor
References
Final results of the prospective European trial of the Endurant stent graft for endovascular abdominal aortic aneurysm repair. [2011]The Endurant Stent Graft System (Medtronic Vascular, Santa Rosa, CA) is specifically designed to treat patients with abdominal aortic aneurysm, including those with difficult anatomies. This is the 1-year report of a prospective, non-randomised, open-label trial at 10 European centres.
Long-term results after standard endovascular aneurysm repair with the Endurant and Excluder stent grafts. [2020]Many endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts.
One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial. [2022]To report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis system in the US regulatory trial.
Improved effectiveness of the repositionable GORE EXCLUDER AAA endoprosthesis featuring the C3 delivery system compared with the original GORE EXCLUDER AAA endoprosthesis for within the instructions for use treatment of aortoiliac aneurysms. [2019]To compare two endograft types, the original GORE EXCLUDER AAA endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) with the repositionable GORE EXCLUDER featuring the C3 delivery system, which allows repositioning of the proximal part of the graft to achieve accurate placement in relation to the renal arteries, in unselected patients with aortoiliac aneurysms. In a second nested, substudy we investigated the relative effect of the standard Gore and Gore Dryseal introducer sheaths on intraoperative transfusion needs.
Initial human experience with the GORE EXCLUDER Conformable AAA Endoprosthesis. [2020]Endovascular repair has become the standard of care for treatment of abdominal aortic aneurysms. The endografts and delivery systems for endovascular aneurysm repair have undergone multiple generations of technologic advancements. However, a significant remaining challenge for a satisfactory long-term outcome is to improve the performance of these devices in nonideal proximal sealing zones. In particular, short (60 degrees) necks can threaten long-term exclusion of the aneurysm even with the current generation of endografts. One of the main reasons for proximal infrarenal neck failure is the inability to accurately position the endograft precisely below both renal arteries. This is a report of the first-in-human implantations of the GORE EXCLUDER Conformable AAA Endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz), an investigational device, in anatomies with standard neck lengths and angulation. This device has been designed to provide repositionability, conformability, and, for the first time, optional angulation control. This device is commercially available in Europe.
One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft. [2022]The Endurant (Medtronic, Minneapolis, Minn) is a new stent graft specifically designed to make more patients anatomically eligible for endovascular aneurysm (EVAR). This study presents the 1-year results of 100 consecutive patients with abdominal aortic aneurysms (AAAs) treated with the Endurant stent graft in real-life practice.
Results of endovascular repair of infrarenal aortic aneurysms using the Endurant stent graft. [2014]Recent reports showed that the Endurant stent graft (Medtronic Cardiovascular, Santa Rosa, Calif) is safe and effective for endovascular repair of abdominal aortic aneurysms (AAAs). However, due to its relatively recent introduction, only short-term follow-up data are available. This study presents the 4-year results using this device.
The use of Endurant stent-graft for abdominal aortic aneurysm: the story about extension of instruction for use with persistent good results of stent-graft latest generation. [2016]The Endurant stent-graft (Medtronic, Inc., Minneapolis, MN, USA) is a latest generation device for the treatment of abdominal aortic aneurysm. The idea behind designing such a graft came from the intention to broad the instruction for use (IFU) and to enable it to treat more challenging anatomy including the 10mm neck lengths, and more severe suprarenal and infrarenal angulations. Endurant stent-graft has active fixation through suprarenal stent with anchoring pins to provide migration resistance, optimized heights of stents and spacing between them for improved flexibility and conformability, low-profile delivery system with hydrophilic coating and controlled simple deployment mechanism. Short term results are excellent. Technical and clinical success is confirmed in Regulatory trials (EU and USA), as well as in ENGAGE and the Canadian registry. Many current publications record the use of Endurant stent-graft outside the Instruction for use. The results in a group of patients outside the instruction for use are comparable to those within instruction for use; with the exception of perioperative proximal endoleak type I. Mid-term results are consistent with short-term results. The long-term results are lacking.
Late abdominal aortic aneurysm enlargement after endovascular repair with the Excluder device. [2016]Behavior of the abdominal aortic aneurysm (AAA) sac after endovascular abdominal aortic aneurysm repair (EVAR) is graft-dependent. The Excluder endograft has been associated with less sac regression than some other stent grafts. Long-term follow-up has not been reported.