N/A
N=276
A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01118117 ↗Enrolled (actual)
276
Serious AEs
49.3%
Results posted
Jul 2015
Primary outcome: Primary: Primary Effectiveness Endpoint — 54.0 percentage of stent patency
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Misago™ Self-Expanding Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terumo Medical Corporation
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint |
54.0 | — |
| PRIMARY Primary Safety Endpoint |
99.2; 100 | — |
| SECONDARY Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort |
62.4 | — |
| SECONDARY Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort |
69.9 | — |
| SECONDARY Occurrence of Target Lesion Revascularization |
13.0 | — |
| SECONDARY Device Related Peri-Procedural Complications |
2.3 | — |
| SECONDARY Technical Success |
100; 93.3 | — |
| SECONDARY Procedural Success |
93.5; 100 | — |
| SECONDARY Clinical Success |
90.0; 92.9 | — |
| SECONDARY Major Adverse Events (MAEs) Through 12 Months Post-procedure |
16.1 | — |
| SECONDARY Stent Fracture at 12 Months |
0.9 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
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 50% stenosis, or occlusion which require treatment, and a total lesion length of >40 mm and 4.0 mm and 40 mm and 50%) and at least one patent tibioperoneal run-off vessel with < 50% stenosis confirmed by angiography within 30 days of enrollment.
Exclusion Criteria
- 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.
- 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.*
Data sourced from ClinicalTrials.gov (NCT01118117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.