Skip to main content
OpenTrials
Completed

NCT Number: NCT02793492

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iliac Artery Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ClinRe Inc. Advanced Heart and Vein Center, Thornton, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is ≥ 18 years old and of legal consent.
  • Is willing to comply with all follow-up evaluations at the specified times.
  • 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.
  • 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.

Exclusion criteria

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

Treatment and study plan

Misago® RX Self-expanding Peripheral Stent

Device

the Misago® RX Self-expanding Stent is a bare metal, nitinol stent

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. Ankle Brachial Index (ABI) change from baseline

    Time frame: through 9 months post-procedure

  7. 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).

  8. 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

  9. Walking Impairment Questionnaire

    Time frame: change from baseline (pre-procedure) at 30 days and 9 months post procedure

  10. Evaluation of all AEs

    Time frame: pre-discharge through 24 months post-procedure

  11. 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

  12. 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

  13. Device Related Complications

    Time frame: 9 months post-procedure

Sponsors and collaborators

Lead sponsor

Terumo Medical Corporation

Industry

Registry information

Official study title

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

Acronym: OSPREY ILIAC

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 8, 2016
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.