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

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: Active, not recruiting
• Conditions: Iliac Artery Stenosis
• Intervention / Treatment: Device: Misago® RX Self-expanding Peripheral Stent

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	9 months post-procedure

Secondary Outcome Measures

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.		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	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.	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.	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		through 9 months post-procedure
Walking Impairment Questionnaire		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.		The event is assessed from time of enrollment through hospital discharge or up to 7 days post procedure, whichever occurs first
Device Related Complications		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.		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	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.	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		pre-discharge through 24 months post-procedure
Occurrence of device deficiency	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

• Sponsor: Terumo Medical Corporation
• Investigators: Principal Investigator: John Rundback, MD, Holy Name Medical Center; Study Director: Charis Sugden, Terumo Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): February 24, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimated): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID 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