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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02574481




Registration number
NCT02574481
Ethics application status
Date submitted
22/09/2015
Date registered
14/10/2015
Date last updated
27/01/2020

Titles & IDs
Public title
ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent
Scientific title
A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries
Secondary ID [1] 0 0
S2063
Universal Trial Number (UTN)
Trial acronym
IMPERIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis of Native Arteries of the Extremities 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ELUVIA (Stent Implantation)
Treatment: Devices - Zilver PTX (Stent Implantation)

Experimental: ELUVIA Stent Implantation - Percutaneous stent placement in the SFA/PPA

Active Comparator: Zilver PTX Stent Implantation - Percutaneous stent placement in the SFA/PPA


Treatment: Devices: ELUVIA (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.

Treatment: Devices: Zilver PTX (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
12 Months
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
12 Months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
12 Months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
12 Months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline to 12 Months
Secondary outcome [5] 0 0
6-Minute Walk Test - Distance Walked - Change in distance walked from baseline to 12 months.
Timepoint [5] 0 0
Change in baseline to 12-Months
Secondary outcome [6] 0 0
6-Minute Walk Test - Speed - Change in speed walked from baseline to 12 months
Timepoint [6] 0 0
Baseline to 12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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California
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Florida
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Georgia
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Illinois
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Indiana
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Nebraska
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New Hampshire
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New Jersey
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New Mexico
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Oregon
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Pennsylvania
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South Dakota
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Tennessee
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Texas
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United States of America
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Wisconsin
Country [23] 0 0
Austria
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Graz
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Austria
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Vienna
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Tienen
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Canada
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Ontario
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Canada
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Quebec
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Germany
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Bad Krozingen
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Germany
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Berlin
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Germany
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Flensburg
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Germany
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Leipzig
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Nara
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Japan
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Osaka
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Japan
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Tokyo
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New Zealand
State/province [40] 0 0
Auckland
Country [41] 0 0
New Zealand
State/province [41] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02574481
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Gray, MD
Address 0 0
Main Line Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications