Iliac Artery StenosisOSPREY ILIACNCT02793492
Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery
A study testing Misago® RX Self-expanding Peripheral Stent in people with Iliac Artery Stenosis, run by Terumo Medical Corporation at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iliac Artery Stenosis
- What is being tested?
- Misago® RX Self-expanding Peripheral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Aug 2022to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
The Christ Hospital
Cincinnati, Ohio, 45219
University of Florida Health
Gainesville, Florida, 32610
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Cardiovascular Institute of the South
Lafayette, Louisiana, 70506
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Novant Health
Matthews, North Carolina, 28105
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Holy Name Medical Center
Teaneck, New Jersey, 07666
ClinRe Inc. Advanced Heart and Vein Center
Thornton, Colorado, 80023
About this study
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
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.
- Conditions
- Iliac Artery Stenosis
- Being tested
- Misago® RX Self-expanding Peripheral Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misago® RX Self-expanding Peripheral StentDevice
the Misago® RX Self-expanding Stent is a bare metal, nitinol stent
| Study group | Role | What they receive |
|---|---|---|
| Misago® RX Self-expanding Stent | Experimental | Eligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent Receives: Device: Misago® RX Self-expanding Peripheral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months post-procedure
Secondary outcomes (13)
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.
Measured: 30 days, 12- and 24- 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.
Measured: 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
Technical success will be evaluated from time of enrollment through index procedure
Measured: The outcome is assessed up to 24 hours from time of enrollment through index procedure.
Procedural Success: Attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications.
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.
Measured: The outcome is assessed up to 24 hours from time of enrollment through index procedure
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.
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.
Measured: 30 days post-procedure
Ankle Brachial Index (ABI) change from baseline
Measured: through 9 months post-procedure
Clinically driven Target Vessel Revascularization (TVR) at 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).
Measured: 30 days and 9, 12 and 24 months post-procedure
Clinically driven TLR through 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
Measured: 30 days and 9-, 12- and 24-months post-procedure
Walking Impairment Questionnaire
Measured: change from baseline (pre-procedure) at 30 days and 9 months post procedure
Evaluation of all AEs
Measured: pre-discharge through 24 months post-procedure
Evaluation of access site complications including severe bleeding, hematoma, and pseudoaneurysm, occurring prior to hospital discharge.
Measured: 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
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
Measured: through 24 months post-procedure
Device Related Complications
Measured: 9 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start30 Aug 2022
- Primary completion24 Feb 2025
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Rundback, MD, Principal investigator, Holy Name Medical CenterCharis Sugden, Study director, Terumo Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793492
- Sponsor's protocol ID
- TIS2015-01
- Acronym
- OSPREY ILIAC
- Status last verified
- Jul 2026
- First submitted
- 16 May 2016
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02793492
- Acronym / sponsor ID
- OSPREY ILIAC / TIS2015-01
- Conditions
- Iliac Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Terumo Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Misago® RX Self-expanding Stent | Experimental | Device: Misago® RX Self-expanding Peripheral StentEligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misago® RX Self-expanding Peripheral Stentthe Misago® RX Self-expanding Stent is a bare metal, nitinol stent | Device | Misago® RX Self-expanding Stent |
Primary outcome
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
13 secondary outcomes
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
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.
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
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
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- and 24- months post-procedure
Time frame: 30 days and 9, 12 and 24 months post-procedure
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
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 24 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 24 months post-procedure
Device Related Complications
Time frame: 9 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Rundback, MD principal investigator
Holy Name Medical Center
Charis Sugden study director
Terumo Medical Corporation
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misago® RX Self-expanding Peripheral Stent in people with Iliac Artery Stenosis, run by Terumo Medical Corporation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.