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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
Date last updated
8/05/2023

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)
Timepoint [1] 0 0
12 Months
Primary outcome [2] 0 0
Number of Participants Reaching Primary Patency
Timepoint [2] 0 0
12 Months
Secondary outcome [1] 0 0
Number of CEC-adjudicated Events Through 12 Months
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
Count of Participants Meeting Primary Sustained Clinical Improvement
Timepoint [2] 0 0
12 Months
Secondary outcome [3] 0 0
Number of Participants With Hemodynamic Improvement
Timepoint [3] 0 0
12 Months
Secondary outcome [4] 0 0
Walking Impairment Questionnaire (WIQ) Scores
Timepoint [4] 0 0
Baseline to 12 Months
Secondary outcome [5] 0 0
6-Minute Walk Test - Distance Walked
Timepoint [5] 0 0
Change in baseline to 12-Months
Secondary outcome [6] 0 0
6-Minute Walk Test - Speed
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
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Arizona
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California
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Florida
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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Maine
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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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North Carolina
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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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United States of America
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Texas
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United States of America
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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
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Gent
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Belgium
State/province [28] 0 0
Tienen
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Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
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Quebec
Country [31] 0 0
Germany
State/province [31] 0 0
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
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
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/study/NCT02574481
Trial related presentations / publications
Iida O, Fujihara M, Kawasaki D, Mori S, Yokoi H, Miyamoto A, Kichikawa K, Nakamura M, Ohki T, Diaz-Cartelle J, Muller-Hulsbeck S, Gray WA, Soga Y. 24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent. Cardiovasc Intervent Radiol. 2021 Sep;44(9):1367-1374. doi: 10.1007/s00270-021-02901-6. Epub 2021 Jul 7.
Muller-Hulsbeck S, Benko A, Soga Y, Fujihara M, Iida O, Babaev A, O'Connor D, Zeller T, Dulas DD, Diaz-Cartelle J, Gray WA. Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent. Cardiovasc Intervent Radiol. 2021 Mar;44(3):368-375. doi: 10.1007/s00270-020-02693-1. Epub 2020 Nov 22.
Golzar J, Soga Y, Babaev A, Iida O, Kawasaki D, Bachinsky W, Park J, Prem JT, Vermassen F, Diaz-Cartelle J, Muller-Hulsbeck S, Gray WA. Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent. J Endovasc Ther. 2020 Apr;27(2):296-303. doi: 10.1177/1526602820901723. Epub 2020 Jan 28.
Soga Y, Fujihara M, Iida O, Kawasaki D, Hirano K, Yokoi H, Miyamoto A, Kichikawa K, Nakamura M, Ohki T, Diaz-Cartelle J, Gray WA, Muller-Hulsbeck S. Japanese Patients Treated in the IMPERIAL Randomized Trial Comparing Eluvia and Zilver PTX Stents. Cardiovasc Intervent Radiol. 2020 Feb;43(2):215-222. doi: 10.1007/s00270-019-02355-x. Epub 2019 Nov 5.
Gray WA, Keirse K, Soga Y, Benko A, Babaev A, Yokoi Y, Schroeder H, Prem JT, Holden A, Popma J, Jaff MR, Diaz-Cartelle J, Muller-Hulsbeck S; IMPERIAL investigators. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. 2018 Oct 27;392(10157):1541-1551. doi: 10.1016/S0140-6736(18)32262-1. Epub 2018 Sep 24.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02574481