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

N/A

Waitlist Available

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

Must not have

Has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 36 months post-procedure

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic or cannot take certain blood thinning or clot-dissolving medications.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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.

Clinically driven Target Vessel Revascularization (TVR) at 30 days and 9, 12, 24, and 36 months post-procedure

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