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Device

Aortoseal for Abdominal Aortic Aneurysm

N/A
Waitlist Available
Led By Ross Milner, MD
Research Sponsored by Endoron Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a device called the Aortoseal Endostapling System in patients who have had or are going to have treatment for an abdominal aortic aneurysm. The device

Who is the study for?
This trial is for patients with an abdominal aortic aneurysm (AAA) who are suitable for elective repair using an Endovascular Graft System, or those who have already had such a graft placed. It's not specified who can't join the trial.
What is being tested?
The Aortoseal Endostapling System is being tested to see if it can better secure and seal endovascular grafts to the aorta in patients with AAA, either during initial treatment or after they've already received a graft.
What are the potential side effects?
Potential side effects aren't detailed here, but generally, procedures involving endovascular grafts may include risks of bleeding, infection, blood vessel damage, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an abdominal aortic aneurysm that can be treated with a specific type of surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Access Site Complications
All Adverse Events
Device Technical Success
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Aortoseal Endostapling SystemExperimental Treatment1 Intervention
Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study

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Who is running the clinical trial?

Endoron MedicalLead Sponsor
Ross Milner, MDPrincipal InvestigatorProfessor of Surgery Chief, Vascular Surgery and Endovascular Therapy
1 Previous Clinical Trials
102 Total Patients Enrolled
Jean PannetonPrincipal InvestigatorProfessor of Surgery, Chief - Division of Vascular Surgery, Eastern Virginia Medical School
~17 spots leftby Sep 2029
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