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Trial record 4 of 27 for:    OSPREY
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Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery (OSPREY ILIAC)

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ClinicalTrials.gov Identifier: NCT02793492
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : January 5, 2023
Sponsor:
Information provided by (Responsible Party):
Terumo Medical Corporation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Iliac Artery Stenosis Device: Misago® RX Self-expanding Peripheral Stent Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OSPREY ILIAC: Occlusive/Stenotic Peripheral Artery REvascularization StudY for Common and/or External ILIAC Artery Using the Misago® RX Self-expanding Peripheral Stent
Actual Study Start Date : August 30, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2026
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Major Adverse Event rate at 30 days, and 12, 24, and 36 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, 24, and 36 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, 24, and 36 months post-procedure [ Time Frame: 30 days and 9, 12, 24, and 36 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, 24, and 36 months post-procedure. [ Time Frame: 30 days and 9, 12, 24, and 36 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 36 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 36 months post-procedure ]
    n 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Resting ABI of < 0.9, or abnormal exercise ABI in the index limb.
  6. 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793492


Contacts
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Contact: Keli Sapp 1-800-283-7866 ext 4931 keli.sapp@terumomedical.com
Contact: Debbie Jackson 1-800-283-7866 ext 7025 debbie.jackson@terumomedical.com

Locations
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United States, Florida
University of Florida Health Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Nancy Hanson         
Principal Investigator: Samir Shah         
First Coast Cardiovascular Institute Recruiting
Jacksonville, Florida, United States, 32256
Contact: Amy Suphachinda         
Principal Investigator: Yazan Khatib, MD         
Northside Hospital Not yet recruiting
Saint Petersburg, Florida, United States, 33709
Contact: Michelle Nelson         
Principal Investigator: Amit Srivastava, MD         
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Lafayette, Louisiana, United States, 70506
Contact: Nichol Charles         
Principal Investigator: Ankur Lodha, MD         
United States, New Jersey
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Angelee Butters         
Principal Investigator: John Runback, MD         
United States, North Carolina
Novant Health Recruiting
Matthews, North Carolina, United States, 28105
Contact: Tara Villalta         
Principal Investigator: Gabriel Delgado, MD         
United States, Texas
Ascension Seton, Ascension Texas Cardiovascular Recruiting
Kyle, Texas, United States, 78640
Contact: Sarah Benedict         
Principal Investigator: Vamsi Krishna, MD         
Texas Tech University Health Sciences Center Recruiting
Lubbock, Texas, United States, 79430
Contact: Maxim Yeremenko         
Principal Investigator: Mohammad Ansari, MD         
Baylor Scott & White, The Heart Hospital Not yet recruiting
Plano, Texas, United States, 75093
Contact: Walter Cerqueira         
Principal Investigator: Sameh Sayfo, MD         
Sponsors and Collaborators
Terumo Medical Corporation
Investigators
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Principal Investigator: John Rundback, MD Holy Name Medical Center
More Information
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Responsible Party: Terumo Medical Corporation
ClinicalTrials.gov Identifier: NCT02793492    
Other Study ID Numbers: TIS2015-01
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes