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IMPEDE-FX + Stent Graft for Abdominal Aortic Aneurysm

N/A
Recruiting
Led By Marc Schermerhorn, M.D.
Research Sponsored by Shape Memory Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

"This trial aims to test if using IMPEDE-FX RapidFill alongside standard stent graft treatment can help reduce the size of abdominal aortic aneurysms in patients who are eligible for elective

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include local complications at the implant site, general risks associated with endovascular procedures like bleeding or infection, and any specific reactions to the IMPEDE-FX implants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days

Trial Design

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.

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Who is running the clinical trial?

Shape Memory Medical, Inc.Lead Sponsor
5 Previous Clinical Trials
183 Total Patients Enrolled
NAMSAOTHER
49 Previous Clinical Trials
19,530 Total Patients Enrolled
Marc Schermerhorn, M.D.Principal InvestigatorBeth Israel Deaconess Medical Center
~120 spots leftby Jun 2026
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