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

July 21, 2026 updated by: Terumo Medical Corporation

OSPREY ILIAC: Occlusive/Stenotic Peripheral Artery REvascularization StudY for Common and/or External ILIAC Artery Using the Misago® RX Self-expanding Peripheral Stent

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Thornton, Colorado, United States, 80023
        • ClinRe Inc. Advanced Heart and Vein Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Health
      • Jacksonville, Florida, United States, 32256
        • First Coast Cardiovascular Institute
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Cardiovascular Institute of the South
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center
    • North Carolina
      • Matthews, North Carolina, United States, 28105
        • Novant Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Texas
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Is ≥ 18 years old and of legal consent.
  2. Is willing to comply with all follow-up evaluations at the specified times.
  3. 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.
  4. Has a Rutherford Clinical Category Score of 2, 3 or 4.
  5. 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.

Exclusion Criteria:

  1. Has had previous stent or stent-graft implantation in the target lesion(s).
  2. 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.
  3. Has known hypersensitivity to contrast material that cannot be adequately pretreated.
  4. Has known hypersensitivity to nickel-titanium (nitinol).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Misago® RX Self-expanding Stent
Eligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent
Device: Misago® RX Self-expanding Peripheral Stent
the Misago® RX Self-expanding Stent is a bare metal, nitinol stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Time Frame: 9 months post-procedure
9 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Primary stent patency at 9 months defined by a binary duplex ultrasound peak systolic velocity ratio ≤ 2.4 at the stented target lesion and absence of TLR.
Time Frame: 9 months post-procedure
9 months post-procedure
Technical Success defined by the following conditions: 1) Successful delivery of the stent at the lesion site 2) Stent(s) successfully deployed in lesion with adequate lesion coverage
Time Frame: The outcome is assessed up to 24 hours from time of enrollment through index procedure.
Technical success will be evaluated from time of enrollment through index procedure
The outcome is assessed up to 24 hours from time of enrollment through index procedure.
Procedural Success: Attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications.
Time Frame: The outcome is assessed up to 24 hours from time of enrollment through index procedure
Procedural success will be evaluated from time of enrollment through index procedure. Peri-procedural complications defined as: death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel.
The outcome is assessed up to 24 hours from time of enrollment through index procedure
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.
Time Frame: 30 days post-procedure
Clinical success will be evaluated from time of enrollment through index procedure. In addition, evaluation of Rutherford sustained (without increase of one or more in the score) at 9 months post-procedure from 30 days post-procedure for durability of results.
30 days post-procedure
Ankle Brachial Index (ABI) change from baseline
Time Frame: through 9 months post-procedure
through 9 months post-procedure
Walking Impairment Questionnaire
Time Frame: change from baseline (pre-procedure) at 30 days and 9 months post procedure
change from baseline (pre-procedure) at 30 days and 9 months post procedure
Evaluation of access site complications including severe bleeding, hematoma, and pseudoaneurysm, occurring prior to hospital discharge.
Time Frame: The event is assessed from time of enrollment through hospital discharge or up to 7 days post procedure, whichever occurs first
The event is assessed from time of enrollment through hospital discharge or up to 7 days post procedure, whichever occurs first
Device Related Complications
Time Frame: 9 months post-procedure
9 months post-procedure
Major Adverse Event rate at 30 days, and 12- and 24- months post-procedure defined as a composite of peri-procedural related death, amputation of the target limb, and clinically driven TLR.
Time Frame: 30 days, 12- and 24- months post-procedure
30 days, 12- and 24- months post-procedure
Clinically driven Target Vessel Revascularization (TVR) at 30 days and 9, 12- and 24- months post-procedure
Time Frame: 30 days and 9, 12 and 24 months post-procedure
TVR is defined as any re-intervention or artery bypass surgery involving the target vessel in which the subject has ≥ 50% diameter stenosis with worsening symptoms, or ≥ 70% stenosis without symptoms. The target vessel is defined as the vessel containing the treated lesion (e.g., common and/or external iliac artery).
30 days and 9, 12 and 24 months post-procedure
Clinically driven TLR through 30 days and 9-, 12- and 24-months post-procedure.
Time Frame: 30 days and 9-, 12- and 24-months post-procedure
Clinically driven TLR is defined as re-intervention of the target lesion in which subject has ≥ 50% stenosis with worsening symptoms, or ≥ 70% stenosis without symptoms
30 days and 9-, 12- and 24-months post-procedure
Evaluation of all AEs
Time Frame: pre-discharge through 24 months post-procedure
pre-discharge through 24 months post-procedure
Occurrence of device deficiency
Time Frame: through 24 months post-procedure
A device deficiency has occurred when there is inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by the manufacturer including labelling
through 24 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Terumo Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Rundback, MD, Holy Name Medical Center
  • Study Director: Charis Sugden, Terumo Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TIS2015-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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