N/A
Completed N=528
ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent
Atherosclerosis of Native Arteries of the Extremities
Source: ClinicalTrials.gov NCT02574481 ↗
Enrolled (actual)
528
Serious AEs
79.9%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants With Major Adverse Events (MAEs) — 0; 0; 0; 0 percentage of participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Major Adverse Events (MAEs) |
0; 0; 0; 0; 0.3; 0 | <0.0001 sig |
| PRIMARY Number of Participants Reaching Primary Patency |
231; 106; 40 | <0.0001 sig |
| SECONDARY Number of CEC-adjudicated Events Through 12 Months |
6; 6; 0; 0; 13; 13 | — |
| SECONDARY Count of Participants Meeting Primary Sustained Clinical Improvement |
250; 118; 35 | — |
| SECONDARY Number of Participants With Hemodynamic Improvement |
223; 111; 37 | — |
| SECONDARY Walking Impairment Questionnaire (WIQ) Scores |
33.16; 29.49; 58.67; 18.25; 18.08; 41.21 | — |
| SECONDARY 6-Minute Walk Test - Distance Walked |
323.8; 323.4; 293.5 | — |
| SECONDARY 6-Minute Walk Test - Speed |
55.5; 56.1; 50.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects age 18 and older.
- 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.
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 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
- Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent ( 600,000 mm3 or history of bleeding diathesis.
- Concomitant renal failure with a serum creatinine >2.0 mg/dL.
- Receiving dialysis or immunosuppressant therapy.
- History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within 6 months prior to randomization/enrollment.
- Unstable angina pectoris at the time of randomization/enrollment.
- Pregnant, breast feeding, or plan to become pregnant in the next 5 years.
- 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).
- Septicemia at the time of randomization/enrollment.
- Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of randomization/enrollment.
- Presence of aneurysm in the target vessel.
- Acute ischemia and/or acute thrombosis of the SFA/PPA prior to randomization/enrollment.
- Perforated vessel as evidenced by extravasation of contrast media prior to randomization/enrollment.
- Heavily calcified lesions.
Data sourced from ClinicalTrials.gov (NCT02574481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.