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Peripheral Stent

Self-Expanding Stent for Iliac Artery Stenosis (OSPREY ILIAC Trial)

N/A

Recruiting

Led By John Rundback, MD

Research Sponsored by Terumo Medical Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a Rutherford Clinical Category Score of 2, 3 or 4

Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 36 months post-procedure

Awards & highlights

OSPREY ILIAC Trial Summary

This trial will test a new self-expanding stent to treat de novo, restenotic, or occlusive lesions in the common or external iliac artery.

Who is the study for?

This trial is for adults over 18 with iliac artery stenosis, evidenced by certain abnormal blood flow measurements (ABI) or radiographic evidence of significant narrowing or blockage in the common/external iliac artery. Participants must be able to follow the study's schedule and have given informed consent. Those allergic to specific metals (nickel-titanium), contrast materials, or drugs used in the study cannot join.Check my eligibility

What is being tested?

The Misago® RX Self-expanding Peripheral Stent is being tested on patients with new or recurring narrowings/blockages in their iliac arteries. This single-group study will monitor how well this stent opens up blood vessels and improves blood flow without randomizing participants into different treatment groups.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include pain at the insertion site, bleeding, infection risk increase due to implantation procedure, allergic reactions to stent material or medications used during the process.

OSPREY ILIAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My leg pain is moderate to severe, affecting my daily activities.

Select...

My imaging shows a blockage of more than 50% in my iliac artery.

OSPREY ILIAC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 36 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 36 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 36 months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom from the composite Major Adverse Event rate, defined as periprocedural related death, amputation of the target limb, and clinically driven TLR assessed at 9 months post-procedure.

Secondary outcome measures

Ankle Brachial Index (ABI) change from baseline

Clinical Success: Relief or improvement (without increase of one or more in the score) from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline.

Clinically driven TLR through 30 days and 9, 12, 24, and 36 months post-procedure.

+10 more

OSPREY ILIAC Trial Design

1Treatment groups

Experimental Treatment

Group I: Misago® RX Self-expanding StentExperimental Treatment1 Intervention

Eligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Terumo Medical CorporationLead Sponsor

24 Previous Clinical Trials

10,353 Total Patients Enrolled

John Rundback, MDPrincipal InvestigatorHoly Name Medical Center

1 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Misago® RX Self-expanding Peripheral Stent (Peripheral Stent) Clinical Trial Eligibility Overview. Trial Name: NCT02793492 — N/A

Iliac Artery Stenosis Research Study Groups: Misago® RX Self-expanding Stent

Iliac Artery Stenosis Clinical Trial 2023: Misago® RX Self-expanding Peripheral Stent Highlights & Side Effects. Trial Name: NCT02793492 — N/A

Misago® RX Self-expanding Peripheral Stent (Peripheral Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02793492 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment figure for this trial?

"This trial necessitates the enrollment of 75 eligible participants, who may be recruited from First Coast Cardiovascular Institute in Jacksonville, Florida or Mercy Hospital South in Saint Louis, Missouri."

Answered by AI

Are there numerous sites in the US conducting this trial?

"10 medical clinics are currently contributing to this trial, with the First Coast Cardiovascular Institute in Jacksonville, Mercy Hospital South in Saint Louis, and University of Florida Health in Gainesville among them."

Answered by AI

Has the recruitment period for participants begun?

"The abovementioned study is currently recruiting new participants; the information was initially posted on August 30, 2022 and has recently been updated as of November 28th."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery

2022. "Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02793492.

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