We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent (IMPERIAL)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02574481
First Posted: October 14, 2015
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose

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.


Condition Intervention Phase
Atherosclerosis of Native Arteries of the Extremities Device: ELUVIA (Stent Implantation) Device: Zilver PTX (Stent Implantation) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Primary Safety Endpoint: Major Adverse Events (MAEs) [ Time Frame: 12 Months ]
    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

  • Primary Effectiveness Endpoint: primary patency [ Time Frame: 12 Months ]
    Primary patency of target lesion at 12-months assessed by duplex ultrasound as adjudicated by an independent core laboratory


Other Outcome Measures:
  • Technical success of the stenting procedure [ Time Frame: During Procedure ]
    Technical Success is defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually

  • Procedural success of the stenting procedure [ Time Frame: Within 24 hours of stenting procedure ]
    Procedural Success is defined as technical success with no MAEs noted within 24 hours of the index procedure

  • MAE rate [ Time Frame: 1 Month ]
    MAE rate is defined as all causes of death, target limb major amputation and/or TLR

  • Clinically-driven TLR Rate [ Time Frame: 1 Month, 6 Months, 12 Months, 24 Months, 36 Months, 48 Months and 60 Months ]
    TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure

  • Clinically-driven Target Vessel Revascularization (TVR) Rate [ Time Frame: 1 Month, 6 Months, 12 Months, 24 Months, 36 Months, 48 Months and 60 Months ]
    TVR is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure

  • Adverse Event Rates (unanticipated, major, serious, device/procedure-related) [ Time Frame: 1 Month, 6 Months, 12 Months, 24 Months, 36 Months, 48 Months and 60 Months ]
  • Non-serious non-device/procedure-related Adverse Event Rates [ Time Frame: Through 12 months ]
  • Stent Fracture Rate [ Time Frame: 12 Months, 24 Months and 60 Months ]

    Stent fracture is defined as a break in one or more places of the stent. The following definitions will be used to determine the type and extent of stent fracture (to be assessed by the x-ray core laboratory):

    • Grade 0: No Strut fractures
    • Grade I: single strut fracture
    • Grade II: multiple strut fractures
    • Grade III: stent fracture(s) with preserved alignment of the components
    • Grade IV: stent fracture(s) with mal-alignment of the components
    • Grade V: Stent fracture(s) in a trans-axial spiral configuration

  • Distribution of Rutherford Classification [ Time Frame: 1 Month, 6 Months, 12 Months, 24 Months and 60 Months ]

    Rutherford Classification:

    0 Asymptomatic Normal Treadmill /stress test

    1. Mild claudication Completes treadmill exercise; ankle pressure (AP) after exercise <50mm Hg, but >25 mm Hg less than BP
    2. Moderate claudication Between categories 1 and 3
    3. Severe claudication Cannot complete treadmill exercise and AP after exercise <50 mm Hg
    4. Ischemic rest pain Resting AP <40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) <30 mm Hg
    5. Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema Resting AP <60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP <40 mm Hg
    6. Major tissue loss - extending above MT level Same as Category 5

  • Rate of Primary Sustained Clinical Improvement as assessed by changes in Rutherford Classification [ Time Frame: 1 Month, 6 Months, 12 Months, 24 Months and 60 Months ]
    Endpoint determined to be a success when there is an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR

  • Rate of Secondary Sustained Clinical Improvement as assessed by changes in Rutherford Classification [ Time Frame: 1 Month, 6 Months, 12 Months, 24 Months and 60 Months ]
    Endpoint determined to be a success when there is an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR

  • Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index (ABI) [ Time Frame: 1 Month, 6 Months, 12 Months, 24 Months and 60 Months ]
    Hemodynamic improvement defined as Improvement of ABI by ≥0.1 or to an ABI ≥ 0.90 as compared to the pre-procedure value without the need for repeat revascularization

  • Walking Improvement assessed by change in Six Minute Hall Walk (6MHW) from baseline [ Time Frame: 12 Months ]
    The 6MHW measures the maximal walking distance that a patient achieves on a flat, hard surface in a period of 6 minutes (the 6MWT). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism

  • Walking Improvement assessed by change in Walking Impairment Questionnaire (WIQ) [ Time Frame: 1 Month, 6 Months, 12 Months, 24 Months and 60 Months ]
    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

  • Patient Utility Values by change in EQ-5D [ Time Frame: 1 Month, 6 Months, 12 Months, 24 Months and 60 Months ]
    The EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension


Enrollment: 524
Actual Study Start Date: December 2015
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ELUVIA Stent Implantation
Percutaneous stent placement in the SFA/PPA
Device: ELUVIA (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.
Active Comparator: Zilver PTX Stent Implantation
Percutaneous stent placement in the SFA/PPA
Device: Zilver PTX (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574481


  Show 65 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: William Gray, MD Main Line Health
Principal Investigator: Stefan Müller-Hülsbeck, Prof Ev. Luth. Diakonissenanstalt Flensburg
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02574481     History of Changes
Other Study ID Numbers: S2063
First Submitted: September 22, 2015
First Posted: October 14, 2015
Last Update Posted: December 5, 2017
Last Verified: December 2017

Keywords provided by Boston Scientific Corporation:
atherosclerosis
Superficial Femoral Artery (SFA)
Proximal Popliteal Artery (PPA)
lower extremities
stenting
paclitaxel

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases