Self-Expanding Stent for Iliac Artery Stenosis

(OSPREY ILIAC Trial)

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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-center, single arm, non-randomized, prospective clinical study using the Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external iliac artery.

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 data supports the effectiveness of the treatment Misago® RX Self-expanding Peripheral Stent for iliac artery stenosis?

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 artery issues. ^{1 2 3 4 5}

Is the Misago stent generally safe for use in humans?

The Misago stent has been evaluated in several studies for different artery conditions, and these studies generally support its safety in humans. For example, the MISAGO 1 and MISAGO 2 trials assessed its safety in treating blocked or narrowed arteries in the legs, and the OSPREY study evaluated its safety for a specific leg artery condition, all indicating it is generally safe. ^{4 5 6 7 8}

How is the Misago® RX Self-expanding Peripheral Stent treatment different from other treatments for iliac artery stenosis?

The Misago® RX Self-expanding Peripheral Stent is unique because it is a self-expanding stent specifically designed for the iliac arteries, offering a minimally invasive option compared to traditional surgery. It is made from nitinol, a flexible metal that allows it to expand and fit the artery's shape, potentially providing better outcomes for patients with chronic aortoiliac disease compared to other stents. ^{1 2 3 4 9}

Research Team

John Rundback, MD

Principal Investigator

Holy Name Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Ulcerated plaques and focal aneurysms of iliac arteries: treatment with noncovered, self-expanding stents. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

New treatment of iliac artery disease: focus on the Absolute Pro® Vascular Self-Expanding Stent System. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Primary stent placement for recanalization of iliac artery occlusions: using a self-expanding spiral stent. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

Comparative 2-year outcomes of the Misago stent versus other self-expandable nitinol stents for the endovascular treatment of aortoiliac disease. [2023]

5. France pubmed.ncbi.nlm.nih.gov

MISAGO 1: first-in-man clinical trial with Misago nitinol stent. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Nine-Month Outcomes of the DURABILITY Iliac Study on Self-Expanding Stents for Symptomatic Peripheral Artery Disease. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Iliac artery stenosis or obstruction after unsuccessful balloon angioplasty: treatment with a self-expandable stent. [2008]