A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery

Peripheral Vascular Disease Clinical Trial

— OSPREY  

Official title:

A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118117
• Other study ID #: TIS2009-02
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: October 17, 2017
• Start date: July 2010
• Est. completion date: April 2016

Study information

• Verified date: October 2017
• Source: Terumo Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: April 2016
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Pre-procedure:

1. Female or male age greater than or equal to 18 years and of legal consent.

2. Subjects must be willing to comply with the specified follow-up evaluation schedule.

3. Informed consent (signed and dated) prior to any study-related evaluation or procedures.

4. Symptomatic leg ischemia without tissue loss by Rutherford classification (category 2, 3 or 4).

5. Resting ABI of <0.9, or abnormal exercise ABI.

6. 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).

7. 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.

8. Reference vessel diameter of >4.0 mm and <7.0 mm.

9. Target lesion length of > 40 mm and <150 mm.

10. 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.

Exclusion Criteria:

1. Pre-existing autoimmune disease.

2. Pre-existing terminal illness with life expectancy of less than three (3) years.

3. Participation in another investigational device or therapeutic intervention trial within the past three (3) months.

4. Previous enrollment in this study.

5. Previous bypass surgery or stenting in the SFA or distally.

6. Scheduled for a staged procedure to treat lesions within the aorta or run-off after enrollment.

7. Co-existing aneurysmal disease of the aorta, iliac artery, SFA, or popliteal arteries requiring treatment.

8. 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).

9. A recent (< 6 week) history of clinically significant gastrointestinal bleeding, major surgery, myocardial infarction or untreated coagulopathy.

10. Known sensitivity or allergy to aspirin, radiographic contrast agents (that cannot be pre-treated adequately), nitinol, gold, or both heparin and bivalirudin.

11. Angiographic evidence of acute thrombus.

12. Sudden worsening of symptoms in the last 30 days.

13. Subjects with acute/chronic renal dysfunction or estimated glomerular filtration rate (eGFR) <30 ml/min. Chronic hemodialysis subjects are not eligible for this protocol.

14. Severe calcification or excessive tortuosity at target lesion.

15. Subjects unable to tolerate anticoagulant therapy or antiplatelet therapy.

16. Women who are currently pregnant. (A negative pregnancy test for female subjects of child bearing potential is required).

17. The target lesion(s) cannot be successfully crossed with a guide wire.*

18. Lower extremity deep venous thrombosis in the study limb within the prior 30 days.

19. Chronic venous disease with active or recent (< 30 day) skin ulceration.

20. Known or suspected active systemic infection.

21. Two (2) months previous history of non-hemorrhagic stroke and or history of hemorrhagic stroke.

22. Treatment that requires access via upper extremity, popliteal artery, or pedal artery.

23. 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.

24. Use of re-entry, ablative, or atherectomy devices to cross the lesion.*

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Misago™ Self-Expanding Stent System
Transcatheter placement of an intravascular stent(s)

Locations

Country	Name	City	State
United States	Amarillo Heart Clinical Research Institute	Amarillo	Texas
United States	Kings Daughters Medical Center	Ashland	Kentucky
United States	University Of Alabama	Birmingham	Alabama
United States	Bradenton Cardiology Center	Bradenton	Florida
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	South Carolina Heart Center	Columbia	South Carolina
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Central Bucks Specialists	Doylestown	Pennsylvania
United States	Cardiovascular Associates	Elk Grove Village	Illinois
United States	Cardiology Associates of Mobile	Fairhope	Alabama
United States	Hunterdon Cardiovascular Associates	Flemington	New Jersey
United States	Florida Research Network	Gainesville	Florida
United States	Hillsboro Cardiology	Hillsboro	Oregon
United States	University of Iowa Healthcare	Iowa City	Iowa
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	East Tennessee Cardiovascular Research-Turkey Creek Medical Center	Knoxville	Tennessee
United States	Premier Clinical Reesearch	Knoxville	Tennessee
United States	St. Mary Medical Centere Research Institute	Langhorne	Pennsylvania
United States	Central Arkansas Veteran's Healthcare System	Little Rock	Arkansas
United States	Long Beach VA Healthcare Center	Long Beach	California
United States	Centra Cardiovascular Group	Lynchburg	Virginia
United States	Columbia- St. Mary's	Milwaukee	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	Christiana Care	Newark	Delaware
United States	Sentara Medical Group	Norfolk	Virginia
United States	Coastal Vascular and Interventional, PLLC	Pensacola	Florida
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania
United States	Berks Cardiologists, Ltd	Wyomissing	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
Terumo Medical Corporation	Beth Israel Deaconess Medical Center, ClinLogix. LLC, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Months post-procedure
Primary	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.	30 days post-procedure
Secondary	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).	12 Months post-procedure
Secondary	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)	12 Months post-procedure
Secondary	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	12 Months post-procedure
Secondary	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)	Prior to Hosptial Discharge
Secondary	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	Intra-procedure
Secondary	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	Intra-procedure
Secondary	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	30 days post-procedure
Secondary	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.	12 Months post-procedure
Secondary	Stent Fracture at 12 Months	Occurrence of stent fracture as determined by core laboratory analysis	12 Months post-procedure