Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery (OSPREY ILIAC)
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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 :
Recruiting
First Posted : June 8, 2016
Last Update Posted : January 5, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Iliac Artery Stenosis | Device: Misago® RX Self-expanding Peripheral Stent | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Misago® RX Self-expanding Stent
Eligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent
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Device: Misago® RX Self-expanding Peripheral Stent
the Misago® RX Self-expanding Stent is a bare metal, nitinol stent |
- 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 ]
- 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 ]
- 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 ]
- 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
- 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.
- 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.
- Ankle Brachial Index (ABI) change from baseline [ Time Frame: through 9 months post-procedure ]
- 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).
- 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
- Walking Impairment Questionnaire [ Time Frame: change from baseline (pre-procedure) at 30 days and 9 months post procedure ]
- Evaluation of all AEs [ Time Frame: pre-discharge through 36 months post-procedure ]
- 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 ]
- 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
- Device Related Complications [ Time Frame: 9 months post-procedure ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- Resting ABI of < 0.9, or abnormal exercise ABI in the index limb.
- 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).

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
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 |
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 |
Principal Investigator: | John Rundback, MD | Holy Name Medical Center |
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 |
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 |