Peripheral Vascular DiseaseOSPREYNCT01118117
A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
A study testing Misago™ Self-Expanding Stent System in people with Peripheral Vascular Disease, run by Terumo Medical Corporation at 31 sites in United States.
Trial summary
OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral Self Expanding stent once all of the inclusion and none of the exclusion criteria are met. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Misago™ Self-Expanding Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 31 sitesUnited States
- Study dates
- Jul 2010to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pre-procedure:
- Female or male age greater than or equal to 18 years and of legal consent.
- Subjects must be willing to comply with the specified follow-up evaluation schedule.
- Informed consent (signed and dated) prior to any study-related evaluation or procedures.
- Symptomatic leg ischemia without tissue loss by Rutherford classification (category 2, 3 or 4).
- Resting ABI of <0.9, or abnormal exercise ABI.
Show all 11Show fewer
- De novo lesion(s) (one or multiple lesions) with >50% stenosis, or occlusion which require treatment, and a total lesion length of >40 mm and <150 mm of the above-the-knee SFA in one limb. The target lesion should be treatable with no more than two overlapping stents, minimizing the stent overlap up to 10 mm (by visual estimate).
- All lesions are at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and at least 2 cm distal to the origin of the profunda artery.
- Reference vessel diameter of >4.0 mm and <7.0 mm.
- Target lesion length of > 40 mm and <150 mm.
- Patent popliteal artery (no stenosis > 50%) and at least one patent tibioperoneal run-off vessel with < 50% stenosis confirmed by angiography within 30 days of enrollment.
Who cannot join
- Pre-existing autoimmune disease.
- Pre-existing terminal illness with life expectancy of less than three (3) years.
- Participation in another investigational device or therapeutic intervention trial within the past three (3) months.
- Previous enrollment in this study.
- Previous bypass surgery or stenting in the SFA or distally.
- Scheduled for a staged procedure to treat lesions within the aorta or run-off after enrollment.
Show all 24Show fewer
- Co-existing aneurysmal disease of the aorta, iliac artery, SFA, or popliteal arteries requiring treatment.
- Any inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion) that has not been treated prior to enrollment (Treatment of iliac arteries before SFA intervention is permitted, except for common femoral stenosis).
- A recent (< 6 week) history of clinically significant gastrointestinal bleeding, major surgery, myocardial infarction or untreated coagulopathy.
- Known sensitivity or allergy to aspirin, radiographic contrast agents (that cannot be pre-treated adequately), nitinol, gold, or both heparin and bivalirudin.
- Angiographic evidence of acute thrombus.
- Sudden worsening of symptoms in the last 30 days.
- Subjects with acute/chronic renal dysfunction or estimated glomerular filtration rate (eGFR) <30 ml/min. Chronic hemodialysis subjects are not eligible for this protocol.
- Severe calcification or excessive tortuosity at target lesion.
- Subjects unable to tolerate anticoagulant therapy or antiplatelet therapy.
- Women who are currently pregnant. (A negative pregnancy test for female subjects of child bearing potential is required).
- The target lesion(s) cannot be successfully crossed with a guide wire.*
- Lower extremity deep venous thrombosis in the study limb within the prior 30 days.
- Chronic venous disease with active or recent (< 30 day) skin ulceration.
- Known or suspected active systemic infection.
- Two (2) months previous history of non-hemorrhagic stroke and or history of hemorrhagic stroke.
- Treatment that requires access via upper extremity, popliteal artery, or pedal artery.
- Evidence of severe or uncontrolled systemic disease of any condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
- Use of re-entry, ablative, or atherectomy devices to cross the lesion.*
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Amarillo Heart Clinical Research Institute
Amarillo, Texas, 79106
Kings Daughters Medical Center
Ashland, Kentucky, 41101
University Of Alabama
Birmingham, Alabama, 35294
Bradenton Cardiology Center
Bradenton, Florida, 34205
Medical University of South Carolina
Charleston, South Carolina, 29401
University of Virginia
Charlottesville, Virginia, 22908
South Carolina Heart Center
Columbia, South Carolina, 29204
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Central Bucks Specialists
Doylestown, Pennsylvania, 18901
Cardiovascular Associates
Elk Grove Village, Illinois, 60007
Cardiology Associates of Mobile
Fairhope, Alabama, 36532
Hunterdon Cardiovascular Associates
Flemington, New Jersey, 08822
Florida Research Network
Gainesville, Florida, 32605
Hillsboro Cardiology
Hillsboro, Oregon, 97123
University of Iowa Healthcare
Iowa City, Iowa, 52242
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Premier Clinical Reesearch
Knoxville, Tennessee, 37909
East Tennessee Cardiovascular Research-Turkey Creek Medical Center
Knoxville, Tennessee, 37934
St. Mary Medical Centere Research Institute
Langhorne, Pennsylvania, 19047
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, 72205
Long Beach VA Healthcare Center
Long Beach, California, 90822
Centra Cardiovascular Group
Lynchburg, Virginia, 24501
Columbia- St. Mary's
Milwaukee, Wisconsin, 53211
Columbia University Medical Center
New York, New York, 10032
Christiana Care
Newark, Delaware, 19718
Sentara Medical Group
Norfolk, Virginia, 23507
Coastal Vascular and Interventional, PLLC
Pensacola, Florida, 32504
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043
Berks Cardiologists, Ltd
Wyomissing, Pennsylvania, 19610
Michigan Heart
Ypsilanti, Michigan, 48197
About this study
OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral Self Expanding stent once all of the inclusion and none of the exclusion criteria are met. The stent efficacy and safety will be evaluated immediately post procedure, and at 30 days, 6, 12, 24, and 36 months post procedure. A subject is considered enrolled into the OSPREY study after he/she signs the informed consent and meets all inclusion/exclusion criteria.
The study objectives are to demonstrate that efficacy and safety of this novel stent design are not inferior to historical Percutaneous Transluminal Angioplasty (PTA) and stent outcomes and meet the performance goals as published in the objective performance goals by Rocha-Singh, et al. This is a multi-center, single arm, non-randomized, prospective clinical trial of the Misago™ Self-Expanding Stent System for the treatment of atherosclerotic stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated at 12 months.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Misago™ Self-Expanding Stent System
- Keywords
- atherosclerotic stenosis, occlusions, Superficial Femoral Artery, SFA
- Medical subject headings
- Peripheral Vascular Diseases, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misago™ Self-Expanding Stent SystemDevice
Also called Misago, OSPREY
Transcatheter placement of an intravascular stent(s)
| Study group | Role | What they receive |
|---|---|---|
| Misago™ Self-Expanding Stent System | Experimental | Not described Receives: Device: Misago™ Self-Expanding Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window.
Measured: 12 Months post-procedure
Primary Safety Endpoint
The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death.
Measured: 30 days post-procedure
Secondary outcomes (9)
Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort
Primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window. Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success. The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).
Measured: 12 Months post-procedure
Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort
The primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from duplex ultrasound. Additional considerations were made using a more contemporary approach to evaluate stent patency using a peak systolic velocity ratio (PSVR) ≤ 2.4 (i.e., modified VIVA criteria). This outcome evaluated the modified intent-to-treat (mITT) cohort comprised of 226 subjects (excluded subjects with unknown primary effectiveness endpoint)
Measured: 12 Months post-procedure
Occurrence of Target Lesion Revascularization
The occurrence of clinically driven Target Lesion Revascularization (TLR) was measured at 12 months post-procedure.
Clinically driven defined as:
- More than 50 percent stenosis with worsening symptoms, OR
- More than 70 percent stenosis without symptoms
Measured: 12 Months post-procedure
Device Related Peri-Procedural Complications
Peri-procedural (prior to discharge) measure of success (i.e., patency and none of the following: death, stroke, MI, embolization, thrombosis, and occlusion)
Measured: Prior to Hosptial Discharge
Technical Success
Technical Success defined by the following conditions:
- Successful delivery of the stent at the lesion site
- Stent(s) successfully deployed in lesion with adequate lesion coverage
Measured: Intra-procedure
Procedural Success
Procedural success defined as: attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications defined as: death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel
Measured: Intra-procedure
Clinical Success
Clinical success defined as: relief or improvement from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline
Measured: 30 days post-procedure
Major Adverse Events (MAEs) Through 12 Months Post-procedure
The incidence of MAEs occurring within 12 months of the procedure. MAE is defined as target lesion revascularization (TLR), amputation of the treated limb, or death.
Measured: 12 Months post-procedure
Stent Fracture at 12 Months
Occurrence of stent fracture as determined by core laboratory analysis
Measured: 12 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 posted6 May 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2013
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies 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
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
- Investigators
- John F Angle, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118117
- Sponsor's protocol ID
- TIS2009-02
- Acronym
- OSPREY
- Status last verified
- Oct 2017
- First submitted
- 4 May 2010
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.
PubMed 17377972Ohki T, Angle JF, Yokoi H, Jaff MR, Popma J, Piegari G, Kanaoka Y; OSPREY investigators. One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study). J Vasc Surg. 2016 Feb;63(2):370-6.e1. doi: 10.1016/j.jvs.2015.08.093. Epub 2015 Oct 17.
PubMed 26483003Schulte KL, Kralj I, Gissler HM, Bagnaschino LA, Buschmann I, Pernes JM, Haage P, Goverde P, Beregi JP, Valka M, Boudny J, Geibel T, Velkoborsky M, Zahringer M, Paetzel C, Fanelli F, Muller-Hulsbeck S, Zeller T, Langhoff R. MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients. J Endovasc Ther. 2012 Dec;19(6):774-84. doi: 10.1583/JEVT-12-3861MR.1.
PubMed 23210876
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
- ClinicalTrials.gov ID
- NCT01118117
- Acronym / sponsor ID
- OSPREY / TIS2009-02
- Conditions
- Peripheral Vascular Disease
- Keywords
- atherosclerotic stenosis, occlusions, Superficial Femoral Artery, SFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Terumo Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Posted 14 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral Self Expanding stent once all of the inclusion and none of the exclusion criteria are met. The stent efficacy and safety will be evaluated immediately post procedure, and at 30 days, 6, 12, 24, and 36 months post procedure. A subject is considered enrolled into the OSPREY study after he/she signs the informed consent and meets all inclusion/exclusion criteria.
The study objectives are to demonstrate that efficacy and safety of this novel stent design are not inferior to historical Percutaneous Transluminal Angioplasty (PTA) and stent outcomes and meet the performance goals as published in the objective performance goals by Rocha-Singh, et al. This is a multi-center, single arm, non-randomized, prospective clinical trial of the Misago™ Self-Expanding Stent System for the treatment of atherosclerotic stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Misago™ Self-Expanding Stent System | Experimental | Device: Misago™ Self-Expanding Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female or male age greater than or equal to 18 years and of legal consent.
- Subjects must be willing to comply with the specified follow-up evaluation schedule.
- Informed consent (signed and dated) prior to any study-related evaluation or procedures.
- Symptomatic leg ischemia without tissue loss by Rutherford classification (category 2, 3 or 4).
- Resting ABI of <0.9, or abnormal exercise ABI.
Key exclusion criteria (24 listed)
- Pre-existing autoimmune disease.
- Pre-existing terminal illness with life expectancy of less than three (3) years.
- Participation in another investigational device or therapeutic intervention trial within the past three (3) months.
- Previous enrollment in this study.
- Previous bypass surgery or stenting in the SFA or distally.
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™ Self-Expanding Stent SystemAlso: Misago, OSPREYTranscatheter placement of an intravascular stent(s) | Device | Misago™ Self-Expanding Stent System |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 12 Months post-procedure
The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window.
Primary Safety Endpoint
Time frame: 30 days post-procedure
The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death.
9 secondary outcomes
Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort
Time frame: 12 Months post-procedure
Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort
Time frame: 12 Months post-procedure
Occurrence of Target Lesion Revascularization
Time frame: 12 Months post-procedure
Device Related Peri-Procedural Complications
Time frame: Prior to Hosptial Discharge
Technical Success
Time frame: Intra-procedure
Procedural Success
Time frame: Intra-procedure
Clinical Success
Time frame: 30 days post-procedure
Major Adverse Events (MAEs) Through 12 Months Post-procedure
Time frame: 12 Months post-procedure
Stent Fracture at 12 Months
Time frame: 12 Months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17377972Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.
- Derived from this study: PubMed 26483003Ohki T, Angle JF, Yokoi H, Jaff MR, Popma J, Piegari G, Kanaoka Y; OSPREY investigators. One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study). J Vasc Surg. 2016 Feb;63(2):370-6.e1. doi: 10.1016/j.jvs.2015.08.093. Epub 2015 Oct 17.
- Derived from this study: PubMed 23210876Schulte KL, Kralj I, Gissler HM, Bagnaschino LA, Buschmann I, Pernes JM, Haage P, Goverde P, Beregi JP, Valka M, Boudny J, Geibel T, Velkoborsky M, Zahringer M, Paetzel C, Fanelli F, Muller-Hulsbeck S, Zeller T, Langhoff R. MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients. J Endovasc Ther. 2012 Dec;19(6):774-84. doi: 10.1583/JEVT-12-3861MR.1.
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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 F Angle, MD principal investigator
University of Virginia
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misago™ Self-Expanding Stent System in people with Peripheral Vascular Disease, run by Terumo Medical Corporation at 31 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 11 inclusion and 24 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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?
Yes. Results are posted in the registry (first posted 14 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Effectiveness Endpoint (time frame: 12 Months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01118117, which also lists 3 linked publications.
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 20 Nov 2017.