| Registry | NCT05409118 |
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| Status | Withdrawn - This is an EU protocol, and as a company, it was decided to only enroll within the US so this protocol/study is being withdrawn. |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Sponsor | Endologix (Industry) |
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| Conditions | AAA, AAA - Abdominal Aortic Aneurysm |
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| Interventions | Alto Abdominal Stent Graft System, FDA Approved EVAR AAA Graft Systems (Device) |
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| Dates | start 2025-12-01 (estimated), primary completion 2030-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2022-06-08, last updated 2025-08-07 |
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Related Papers Related Patents Related Grants Related Experts
All trials for AAA All trials for AAA - Abdominal Aortic Aneurysm All trials of Alto Abdominal Stent Graft System All trials of FDA Approved EVAR AAA Graft Systems
-Summary
Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints.
Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Alto Abdominal Stent Graft System | Experimental | Device: Alto Abdominal Stent Graft System | Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm. |
| Comparators | Active comparator | Device: FDA Approved EVAR AAA Graft Systems | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm. |
- Alto Abdominal Stent Graft System (Device): Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
- FDA Approved EVAR AAA Graft Systems (Device), also known as Medtronic Endurant, Cook Zenith, Gore Excluder: FDA approved comparator of choice
+Outcome measures
Primary outcomes
- Number of Participants with Freedom from Aneurysm-Related Complications (ARC) [Through 5 Years]: Composite endpoint consisting of aneurysm-related death, aneurysm rupture, conversion to open surgery, type I and III endoleaks, device migration (>10mm), aneurysm sac enlargement (>5mm), occlusion, and freedom from device-related interventions
- Neck Dilation in mm [Through 5 Years]
Secondary outcomes
- Number of Major Adverse Events (MAEs) [[Time Frame: At 30 days and 12 months]]: All-cause mortality, Bowel ischemia, Myocardial infarction, Paraplegia, Renal Failure, Respiratory Failure, Stroke, Index Procedural Blood Loss ≥ 1000mL
- Count of participants All Cause Mortality [At 30 days, 12 months, and annually up to five years]
- Count of participants AAA-related Mortality [At 30 days, 12 months, and annually up to five years]
- Number of Type Ia endoleaks [At 30 days, 12 months, and annually up to five years]
- Number of Type Ib [At 30 days, 12 months, and annually up to five years]
- Number of Type II [At 30 days, 12 months, and annually up to five years]
- Number of Type III [At 30 days, 12 months, and annually up to five years]
- Number of Type IV [At 30 days, 12 months, and annually up to five years]
- Number of Unknown Enooleaks [At 30 days, 12 months, and annually up to five years]
- Number of Secondary interventions [At 30 days, 12 months, and annually up to five years]
- Count of subjects lacking device integrity [At 30 days, 12 months, and annually up to five years]: device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak)
- Count of aneurysm ruptures [At 30 days, 12 months, and annually up to five years]
- Count of participants with conversion to open surgery [At 30 days, 12 months, and annually up to five years]
- Count of participants with type I and III endoleaks [At 30 days, 12 months, and annually up to five years]
- Count of participants with device migration (>10mm) [12 months, and annually up to five years]
- Count of participants with aneurysm sac enlargement (>5mm) [12 months, and annually up to five years]
- Count of subjects with occlusion [30 days, 12 months, and annually up to five years]]
- Number of Participants with Freedom From device-related interventions [30 days, 12 months, and annually up to five years]]
+Eligibility
Sex: All, ages: 21 Years to any
Inclusion Criteria:
* Adult age 21 and older
* Subjects with minimum of 2 year life expectancy
* Subjects have signed the informed consent document
* Subjects with unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
* Patient must be able and willing to comply with all required follow-up exams.
Exclusion Criteria:
* Currently participating in another trial where the primary endpoint has not been reached yet.
* Known allergy to any of the device components
* Pregnant (females of childbearing potential only)
* Known connective tissue disorders
* Known active infection
* Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR.
* Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
+Investigators
- Sean Lyden, MD, Principal investigator, The Cleveland Clinic
- Christopher Kwolek, MD, Principal investigator, Newton-Wellesley Hospital
- Hence Verhagen, MD, PhD, Principal investigator, Erasmus University Study Center