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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02574481
Ethics application status
Date submitted
22/09/2015
Date registered
14/10/2015

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)
Assessment method [1] 0 0
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
Assessment method [2] 0 0
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
Assessment method [1] 0 0
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
Assessment method [2] 0 0
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
Assessment method [3] 0 0
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
Assessment method [4] 0 0
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
Assessment method [5] 0 0
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
Assessment method [6] 0 0
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/04/2022
Sample size
Target
Accrual to date
Final
524
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Austria
State/province [24] 0 0
Graz
Country [25] 0 0
Austria
State/province [25] 0 0
Vienna
Country [26] 0 0
Belgium
State/province [26] 0 0
Genk
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
State/province [28] 0 0
Tienen
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Germany
State/province [31] 0 0
Bad Krozingen
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Flensburg
Country [34] 0 0
Germany
State/province [34] 0 0
Leipzig
Country [35] 0 0
Japan
State/province [35] 0 0
Fukuoka
Country [36] 0 0
Japan
State/province [36] 0 0
Hyogo
Country [37] 0 0
Japan
State/province [37] 0 0
Kanagawa
Country [38] 0 0
Japan
State/province [38] 0 0
Nara
Country [39] 0 0
Japan
State/province [39] 0 0
Osaka
Country [40] 0 0
Japan
State/province [40] 0 0
Tokyo
Country [41] 0 0
New Zealand
State/province [41] 0 0
Auckland
Country [42] 0 0
New Zealand
State/province [42] 0 0
Hamilton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02574481