GPX® Embolic Device: Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches
Study summary
The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years on the date of consent
2. Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits
3. Presents with need for peripheral embolization where there is a desire for distal vessel bed penetration including:
* Vascular tumors (e.g., renal angiomyolipoma, renal cell carcinoma, bone tumors, bleeding tumors, and other vascular tumors)
* Renal embolization
* Portal vein branches
4. Informed consent granted by the patient or legally authorized representative
5. Willing and able to comply with the protocol-specified procedures and assessments
Exclusion Criteria:
1. Requires embolization for any of the following applications: a) Neurovasculature b) Coronary vasculature c) Hemorrhage due to trauma d) Non-tumoral focal/active bleeding sites (e.g., gastrointestinal tract, urinary tract, lung) e) Veins other than portal vein f) Aneurysms g) Endoleaks h) Vascular malformations i) Vessels for flow redistribution
2. Has undergone an embolization procedure within 30 days prior to consent
3. Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine)
4. Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents)
5. Known allergy or hypersensitivity to contrast media that cannot be adequately medicated
6. Pregnant, planning to become pregnant during the study period, or breastfeeding
7. Unresolved systemic infection or localized infection in the targeted region
8. Pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the investigator, would clinically confound the study primary endpoints
9. Existing medical condition which, in the opinion of the investigator, may cause the subject to be intolerant of an occlusion procedure or non-compliant with the protocol or may confound the data interpretation
10. Subject is participating in another device, drug, or procedure clinical investigation and has not completed the study treatment or the other investigation clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)
11. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 12. Patients with drug or alcohol dependency (within 6 months prior to study entry) that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results
Intra-procedural exclusion criteria:
13\. Presence of persistent, flow-limiting vasospasm that is not responsive to chemical or mechanical interventions 14. Presence of collateral pathways potentially endangering normal territories during embolization 15. Blood flow precludes safe delivery of embolic material (e.g., arteriovenous shunting or high, unpredictable flow exists) 16. Anatomy that precludes advancement of the delivery device to target vessel embolization site or delivery of embolic material 17. Dissection in the target vessel 18. The delivery device has already been used with an ionic contrast agent (e.g., Conray® (iothalamate meglumine injection USP 60%), Guerbet)
Primary outcome measure(s)
Freedom from major adverse events (MAEs) — Index procedure through 30-day follow-up MAEs are defined as:
* Nontarget embolization with ischemia in an unintended anatomical area
* Systemic allergic and/or toxic reaction to the GPX Embolic Device
* Catheter entrapment and/or breakage
* Culture-proven abscess in target organ/tissue
* Embolization-related death
Single binomial proportion of successful delivery of the GPX Embolic Device to the target vessel embolization site(s) — During procedure Determined by the investigator at the time of enrollment
Single binomial proportion of successful occlusion of flow immediately beyond the target vessel embolization site(s) — End of procedure Determined by the core lab via comparison of the pre- and final post-embolization images
Trial sites (20)
Facility
City
Region
Status
University of California San Diego Altman Clinical and Translation Research Institute
La Jolla
California
University of Colorado Anschutz Medical Campus
Aurora
Colorado
Northwestern University
Chicago
Illinois
Indiana University Hospital
Indianapolis
Indiana
University of Minnesota
Minneapolis
Minnesota
Washington University - Barnes Jewish Hospital
St Louis
Missouri
Albany Medical Center
Albany
New York
Mount Sinai
New York
New York
Memorial Sloan Kettering Cancer Center
New York
New York
University of North Carolina
Chapel Hill
North Carolina
Atrium Health Carolinas Medical Center
Charlotte
North Carolina
University of Texas Southwestern
Dallas
Texas
MD Anderson Cancer Center - Interventional Radiology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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