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Trial record 4 of 25 for:    OSPREY

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02793492
Recruitment Status : Not yet recruiting
First Posted : June 8, 2016
Last Update Posted : October 20, 2021
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Terumo Medical Corporation

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 101 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
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2026

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




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: through 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 failure through the 36 months post-procedure. [ Time Frame: through 36 months post-procedure ]
    Device failure is defined as use of the device in accordance with the IFU, but does not perform as described in the IFU, and also negatively impacts treatment of the study subject.

  13. Device Related Complications [ Time Frame: 9 months post-procedure ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

Baseline:

  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 (index limb only).
  5. Resting ABI of < 0.9, or abnormal exercise ABI.

    Intra-procedure:

  6. De novo, restenotic, and/or occlusive target lesion(s) located within the native common and/or external iliac artery: proximal point at or distal to the ostium of the common iliac artery and distal point at least 1 cm above the Inferior Epigastric Artery (IEA) as measured by straight anteroposterior (AP) view.
  7. 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.
  8. Total combined length of lesion(s) is ≤ 120 mm as determined by the investigator and is amenable to stenting.
  9. Reference vessel diameter is ≥ 4.0 mm and ≤ 9.0 mm.
  10. Radiographic evidence in the target limb of straight line femoropopliteal flow, either not requiring CFA/SFA/popliteal treatment for significant stenosis (≥ 50% stenosis or occlusion, as confirmed by angiography during the index procedure), OR has undergone successful treatment according to protocol specifications with < 30% residual stenosis and no procedural complications prior to enrollment in the study.
  11. At least one patent infrapopliteal artery to the ankle not requiring intervention (i.e., < 50% stenosis).

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).
  5. In the opinion of investigator, has bleeding diathesis, coagulopathy, and/or known hypercoagulable condition making the patient unsuitable for study participation.
  6. Refuses blood transfusion.
  7. Is female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptives measures or refuses to use contraception throughout the duration of the study.
  8. Has life expectancy of less than 1 year.
  9. Has planned use of thrombectomy, atherectomy, brachytherapy, cryotherapy or laser devices to treat the common and/or external iliac arteries during the index procedure.
  10. Has any planned surgical intervention (requiring in-patient hospitalization) 14 days before or 30 days after the index procedure.
  11. Is currently participating in an investigational drug or other device study that has not yet reached the primary endpoint analysis.
  12. Has known aortic disease requiring intervention within 9 months post index procedure.
  13. In the opinion of the investigator, has one or more of the following co-morbid conditions that may impact the subjects safety and/or participation in the study:

    • History of severe liver disease (i.e. ascites, esophageal varices, liver transplant)
    • Known or suspected active systemic infection or infection within the target limb
    • Undergoing immunosuppressant therapy following organ transplant
    • Chronic Kidney Disease Stage IIIB or worse (i.e., GFR < 45 mL/min)
    • New York Heart Association Classification of III or IV with hospitalization for decompensated heart failure within 30 days of index procedure
    • Recent (within 30 days of index procedure) myocardial infarction
    • Recent (within 30 days of index procedure) hemorrhagic or ischemic stroke
    • Acute thrombophlebitis or deep venous thrombosis in the index limb to be treated
    • Any other co-morbid condition that in the judgment of the investigator precludes safe percutaneous intervention
  14. Guide wire cannot successfully cross the target lesion(s) and re-enter true vessel lumen beyond the lesion(s), and study device cannot be deployed so that its proximal and distal ends will be within the true vessel lumen.*
  15. Aneurysmal target vessel.*
  16. Presence of an acute intraluminal thrombus of the proposed lesion site(s).*
  17. If treatment is required of a non-target lesion distal to the target vessel during the index procedure, the non-target lesion must be successfully treated (residual stenosis < 30% and no procedural complications) prior to treatment of the target lesion and:

    • Be located within the native CFA/SFA/PPA
    • The distal point must be at least 1 cm above the first branch of the tibial trifurcation
  18. Lack of straight-line blood flow to the foot/ankle of the target limb prior to index procedure or inability to achieve straight-line blood flow to the foot/ankle of the target limb through treatment of a non-target lesion in the CFA/SFA/proximal popliteal during index procedure prior to enrollment.*
  19. Perforation, flow-limiting dissection, or other injury requiring additional stenting or surgical intervention prior to the start of target lesion treatment.*

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: Robert Gash 1-800-283-7866 ext 4931 robert.gash@terumomedical.com
Contact: Debbie Jackson 1-800-283-7866 ext 7025 debbie.jackson@terumomedical.com

Sponsors and Collaborators
Terumo Medical Corporation
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Investigators
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Principal Investigator: John Rundback, MD Holy Name Medical Center
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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: October 20, 2021
Last Verified: October 2021

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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