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

• ClinicalTrials.gov Identifier: NCT02793492
• Recruitment Status: Not yet recruiting
• First Posted: June 8, 2016
• Last Update Posted: October 20, 2021
• Sponsor: Terumo Medical Corporation
• Collaborators: Beth Israel Deaconess Medical Center; Massachusetts General Hospital
• Information provided by (Responsible Party): Terumo Medical Corporation

Study Description

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

• 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

Arms and Interventions

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

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 ]

Eligibility Criteria

• 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.*

Contacts and Locations

Contacts

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

• Principal Investigator: John Rundback, MD; Holy Name Medical Center

More Information

• Responsible Party: Terumo Medical Corporation
• ClinicalTrials.gov Identifier: NCT02793492
• Other Study ID Numbers: TIS2015-01
• First Posted: June 8, 2016
• Last Update Posted: October 20, 2021
• Last Verified: October 2021

• 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