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



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:December 2015
End Date:March 2022

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

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.

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.

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.
We found this trial at
40
sites
4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: Daniel Dulas, MD
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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8900 North Kendall Drive
Miami, Florida 33176
Principal Investigator: James Benenati, MD
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Albuquerque, New Mexico 87102
Principal Investigator: Steve Henao, MD
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Augusta, Georgia 30901
Principal Investigator: Patrick Hall, MD
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Boston, Massachusetts 02135
Principal Investigator: Lawrence Garcia, MD
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Boston, MA
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Robert Rhee, MD
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Bryn Mawr, Pennsylvania 19010
Principal Investigator: Antonis Pratsos, MD
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Canton, Ohio 44710
Principal Investigator: Jeffrey Prem, MD
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Chattanooga, Tennessee 37403
Principal Investigator: Mark W Fugate, MD
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Concord, North Carolina 28025
Principal Investigator: Peter O Simon, MD
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Dallas, Texas 75231
Principal Investigator: Tony Das, MD
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Dallas, Texas 75231
Principal Investigator: James Park, MD
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Fort Wayne, Indiana 46802
Principal Investigator: Louis Lopez, MD
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Gainesville, Florida 32605
Principal Investigator: Bret N Wiechmann, MD
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Graz,
Principal Investigator: Hannes Deutschmann, MD
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: David O'Connor, MD
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Jackson, Tennessee 38305
Principal Investigator: Henry Lui, MD
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Jacksonville, Florida 32216
Principal Investigator: Yazan Khatib, MD
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Richard Powell, MD
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Miami Beach, Florida 33140
Principal Investigator: Robert Beasly, MD
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New York, New York 10032
Principal Investigator: Danielle Bajakian, MD
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New York, New York 10021
Principal Investigator: Anvar Babaev, MD
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: Jaafer Golzar, MD
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Ocala, Florida 34471
Principal Investigator: Robert L Feldman, MD
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Omaha, Nebraska 68124
Principal Investigator: Rao Gutta, MD
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Pensacola, Florida 32501
Principal Investigator: Safwan Jaalouk, MD
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Peoria, Illinois 61614
Principal Investigator: John Rashid, MD
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Petoskey, Michigan 49770
Principal Investigator: Jason Ricci, MD
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Principal Investigator: Sean Janzer, MD
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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Portland, Oregon 97225
Principal Investigator: Ethan Korngold, MD
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Raleigh, North Carolina 27607
Principal Investigator: Robert Mendes, MD
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Rochester, Minnesota 55905
Principal Investigator: Randall De Martino, MD
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: John Laird, MD
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Sioux Falls, South Dakota 57108
Principal Investigator: Michael J Bacharach, MD
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Toledo, Ohio 43614
Principal Investigator: Mark Burket, MD
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Wausau, Wisconsin 54401
Principal Investigator: Benjamin Herdrich, MD
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Willoughby, Ohio 44094
Principal Investigator: Vikram Rao, MD
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Wormleysburg, Pennsylvania 17043
Principal Investigator: William Bachinsky, MD
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York, Pennsylvania 17315
Principal Investigator: Paul Tolerico, MD
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Yuma, Arizona 85364
Principal Investigator: Joseph Cardenas, MD
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