Self-Expanding Stent for Iliac Artery Stenosis

(OSPREY ILIAC Trial)

Not currently recruiting at 13 trial locations

Overseen By Charis Sugden

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Terumo Medical Corporation

Must not be taking: Antiplatelets, Anticoagulants, Thrombolytics

Disqualifiers: Previous stent, Contrast allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: Up to 24 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Misago® RX Self-expanding Peripheral Stent to treat blockages in the iliac arteries, which supply blood to the lower body. The goal is to determine if this stent can safely and effectively open these arteries when narrowed or blocked, thereby improving blood flow. Suitable candidates for this trial include those diagnosed with at least a 50% blockage in these arteries and who regularly experience symptoms like leg pain or difficulty walking due to reduced blood flow. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially improve conditions with a new treatment option.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have an allergy to antiplatelet therapy, anticoagulants, or thrombolytic drugs, you may not be eligible to participate.

What prior data suggests that the Misago® RX Self-expanding Peripheral Stent is safe for treating iliac artery stenosis?

Research has shown that the Misago® RX Self-expanding Peripheral Stent is generally safe for treating narrowed iliac arteries. Studies have found good results over two to three years. Most patients tolerated the stent well, with no major safety problems reported. However, the stent should not be used in patients with severe blood clots in the treatment area. This information helps ensure the stent's safe and effective use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Misago® RX Self-expanding Peripheral Stent stands out because it offers a self-expanding design that is specifically tailored for the iliac artery. Unlike traditional balloon-expandable stents, this self-expanding feature allows for a more adaptive fit to the artery's natural shape, potentially reducing risks of artery damage or blockages. Researchers are excited about this treatment as it could provide a more flexible and durable solution for iliac artery stenosis, improving long-term outcomes for patients.

What evidence suggests that the Misago® RX Self-expanding Peripheral Stent is effective for iliac artery stenosis?

Research has shown that the Misago® RX Self-expanding Peripheral Stent is promising for treating iliac artery narrowing. Studies have found positive results lasting up to three years, with its effectiveness comparable to other stents used for this condition. The Misago stent is both safe and effective. Comparisons over two years with other stents for aortoiliac disease suggest that the Misago stent maintains good blood flow. These findings strongly support the stent's ability to successfully treat blocked or narrowed iliac arteries. ^{1 2 3 6 7}

Who Is on the Research Team?

John Rundback, MD

Principal Investigator

Holy Name Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Is willing to comply with all follow-up evaluations at the specified times

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

Subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study

Exclusion Criteria

Has had previous stent or stent-graft implantation in the target lesion(s)

Has known hypersensitivity to contrast material that cannot be adequately pretreated

Has known hypersensitivity to nickel-titanium (nitinol)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo stent implantation with the Misago® RX Self-expanding Stent

Up to 24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Multiple visits at 30 days, 9, 12, and 24 months post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Misago® RX Self-expanding Peripheral Stent

Trial Overview 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.

How Is the Trial Designed?

Group I: Misago® RX Self-expanding Stent Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Terumo Medical Corporation

Lead Sponsor

Trials

25

Recruited

10,400+

Citations

1. withpower.com withpower.com/trial/phase-2-2020-86969

Self-Expanding Stent for Iliac Artery Stenosis · Info for ... The Misago stent has shown positive 2-year outcomes when compared to other similar stents for treating aortoiliac disease, suggesting it is effective for iliac ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12532749/

Three-year clinical outcomes of the Misago stent via ... The Misago stent via TRI for aorto-iliac arterial disease demonstrated acceptable 3-year clinical outcomes. Dialysis and TSAC II C-D were identified as ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140002b.pdf

RX Self-expanding Peripheral Stent - accessdata.fda.gov Acute Performance and Handling, 30 and 90-day in-life, angiographic, gross, and histologic outcomes. This in vivo study was conducted to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36897205/

Comparative 2-year outcomes of the Misago stent versus ... The Misago stent for aortoiliac lesions demonstrated comparable and acceptable clinical results of safety and efficacy for up to 2 years compared with other ...

5. ctv.veeva.com ctv.veeva.com/study/misago-r-rx-self-expanding-peripheral-stent-for-common-and-or-external-iliac-artery

Misago® RX Self-expanding Peripheral Stent for Common ... Has a Rutherford Clinical Category Score of 2, 3 or 4. Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not ...

6. terumo.com terumo.com/newsrelease/detail/20230118/5621

First Patient Treated and Enrolled in Terumo Medical ... ... Misago® RX Self-expanding Peripheral Stent is safe and effective ... data around the benefits of addressing peripheral arterial disease via ...

7. terumois.com terumois.com/en-us/procedural/r2p/misago/r2p-misago-ifu.pdf

R2P™ MISAGO® IFU The Misago RX Self-expanding Peripheral Stent is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or ...