ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent

Atherosclerosis of Native Arteries of the Extremities Clinical Trial

— IMPERIAL  

Official title:

A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574481
• Other study ID #: S2063
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: April 12, 2022

Study information

• Verified date: April 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length.

Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.

Description:

Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion.

The IMPERIAL trial is a global, prospective, multi-center trial. Approximately 525-535 subjects will be enrolled at up to 75 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand.

The trial consists of a prospective, multicenter, 2:1 randomized (ELUVIA vs Zilver PTX), controlled, single-blind, non-inferiority trial (RCT), a concurrent, non-blinded, non-randomized, single-arm, pharmacokinetic (PK) substudy and a concurrent, non-blinded, non-randomized, Long Lesion substudy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: April 12, 2022
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects age 18 and older.

2. Subject (or Legal Guardian if applicable) is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits. NOTE: For subjects less than 20 years of age enrolled at a Japanese center, the subject's legal representative, as well as the subject, must provide written informed consent.

3. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4.

4. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA:

• Degree of stenosis = 70% by visual angiographic assessment

• Vessel diameter = 4 and = 6 mm

• Total lesion length (or series of lesions) = 30 mm and = 140 mm (Note: Lesion segment(s) must be fully covered with one ELUVIA stent or up to two Zilver PTX stents)

• Long Lesion Substudy: Total lesion length (or series of lesions) >140 mm and = 190 mm (Note: Lesion segment(s) will require overlapping of two ELUVIA stents).

• For occlusive lesions requiring use of re-entry device, lesion length = 120 mm

• Long Lesion Substudy: For occlusive lesions requiring use of re-entry device, lesion length > 120 mm and = 170 mm

• Target lesion located at least three centimeters above the inferior edge of the femur

5. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot with no planned intervention.

Exclusion Criteria:

1. Previously stented target lesion/vessel.

2. Target lesion/vessel previously treated with drug-coated balloon <12 months prior to randomization/enrollment.

3. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease.

4. Use of atherectomy, laser or other debulking devices in the target limb SFA/PPA during the index procedure.

5. History of major amputation in the target limb.

6. Documented life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical trial.

7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.

8. Known hypersensitivity/allergy to the investigational stent system or protocol related therapies (e.g., nitinol, paclitaxel, or structurally related compounds, polymer or individual components, and antiplatelet, anticoagulant, thrombolytic medications).

9. Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.

10. Concomitant renal failure with a serum creatinine >2.0 mg/dL.

11. Receiving dialysis or immunosuppressant therapy.

12. History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within 6 months prior to randomization/enrollment.

13. Unstable angina pectoris at the time of randomization/enrollment.

14. Pregnant, breast feeding, or plan to become pregnant in the next 5 years.

15. Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current study endpoints (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies).

16. Septicemia at the time of randomization/enrollment.

17. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of randomization/enrollment.

18. Presence of aneurysm in the target vessel.

19. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to randomization/enrollment.

20. Perforated vessel as evidenced by extravasation of contrast media prior to randomization/enrollment.

21. Heavily calcified lesions.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of Native Arteries of the Extremities

Intervention

Device:
• ELUVIA (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.
• Zilver PTX (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.

Locations

Country	Name	City	State
Austria	Medical University Graz, Department of Radiology	Graz
Austria	Allgemeines Krankenhaus AKH	Vienna
Austria	Hanusch Hospital	Vienna
Belgium	Ziekenhuis oost Limburg	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Regionaal Ziekenhuis Heilig Hart Tienen	Tienen
Canada	Fleurimont Hospital	Sherbrooke	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Germany	Universitäts-Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Center for Diagnostic Radiology and Minimally Invasive Therapy at The Jewish Hospital Berlin	Berlin
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	Ev. Luth. Diakonissenanstalt Flensburg	Flensburg
Germany	Universität Leipzig	Leipzig
Japan	Kansai Rosai Hospital	Amagasaki	Hyogo
Japan	Fukuoka Sanno Hospital	Fukuoka
Japan	Nara Medical University Hospital	Kashihara-shi	Nara
Japan	Takatsu General Hospital	Kawasaki	Kanagawa
Japan	Kishiwada Tokushukai Hospital	Kishiwada	Osaka
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Toho University Ohashi Medical Center	Meguro	Tokyo
Japan	The Jikei University Hospital	Minato	Tokyo
Japan	Morinomiya Hospital	Osaka
Japan	Saiseikai Yokohama-City Eastern Hospital	Yokohama	Kanagawa
New Zealand	Auckland City Hospital	Auckland
New Zealand	Middlemore Hospital	Auckland
New Zealand	Clinical Trials NZ	Hamilton
United States	New Mexico Heart Institute, PA	Albuquerque	New Mexico
United States	University Hospital	Augusta	Georgia
United States	Steward St. Elizabeth's Medical Center of Boston, Inc.	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	Lankenau Institute for Medical Research	Bryn Mawr	Pennsylvania
United States	Aultman Hospital	Canton	Ohio
United States	University Surgical Associates	Chattanooga	Tennessee
United States	Carolinas HealthCare System NorthEast	Concord	North Carolina
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Texas Health Presbyterian Hospital	Dallas	Texas
United States	St. Joseph Hospital	Fort Wayne	Indiana
United States	Florida Research Network, LLC	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	Jackson-Madison County General Hospital	Jackson	Tennessee
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	St. Thomas Research Institute, LLC	Nashville	Tennessee
United States	New York Presbyterian Hospital-Columbia University Medical Center	New York	New York
United States	New York University Medical Center	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	MediQuest Research at Munroe Regional Medical Center	Ocala	Florida
United States	Alegent Creighton Health Bergan Mercy Medical Center	Omaha	Nebraska
United States	Baptist Hospital	Pensacola	Florida
United States	St. Francis Medical Center	Peoria	Illinois
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Maine Medical Center	Portland	Maine
United States	Providence St. Vincents Medical Center	Portland	Oregon
United States	Rex Hospital	Raleigh	North Carolina
United States	Mayo Clinic Foundation	Rochester	Minnesota
United States	University of California, Davis Medical Center	Sacramento	California
United States	Avera Heart Hospital of South Dakota	Sioux Falls	South Dakota
United States	University of Toledo Medical Center	Toledo	Ohio
United States	Aspirus Heart and Vascular Institute - Research and Education	Wausau	Wisconsin
United States	LakeWest Hospital/Northeast Ohio Vascular Associates, Inc.	Willoughby	Ohio
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania
United States	York Hospital	York	Pennsylvania
United States	Yuma Regional Medical Center	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Germany,  Japan,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Freedom From Major Adverse Events	Percentage of participants without Major Adverse Events (MAEs)	Through 60 Months
Other	Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate	Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization rate	Through 60 Months
Other	Percentage of Participants With Target Limb Major Amputation	Clinical Events Committee (CEC) adjudicated target limb major amputation rate	Through 60 Months
Primary	Percentage of Participants With Major Adverse Events (MAEs)	MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months	12 Months
Primary	Number of Participants Reaching Primary Patency	Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory	12 Months
Secondary	Number of CEC-adjudicated Events Through 12 Months	Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.	12 Months
Secondary	Count of Participants Meeting Primary Sustained Clinical Improvement	Defined as improvement in Rutherford classification (defined as chronic, symptomatic lower limb ischemia in categories 2, 3 or 4) by one or more categories compared with baseline, without target lesion revascularization.	12 Months
Secondary	Number of Participants With Hemodynamic Improvement	Defined as an increase in the ankle-brachial index by greater than of equal to 0.10 compared with baseline or to an ankle-brachial index of greater than or equal to 0.90, without need for repeat target lesion revascularization.	12 Months
Secondary	Walking Impairment Questionnaire (WIQ) Scores	The WIQ is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. WIQ scores reported as change from baseline.	Baseline to 12 Months
Secondary	6-Minute Walk Test - Distance Walked	Change in distance walked from baseline to 12 months.	Change in baseline to 12-Months
Secondary	6-Minute Walk Test - Speed	Change in speed walked from baseline to 12 months	Baseline to 12 months