Clinical trial NCT01820637: Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
Official title: Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project With Boston Scientific's Innova Drug Eluting Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis of Native Arteries of the Extremities
Keywords: atherosclerosis
SFA
PPA
lower extremities
stenting
paclitaxel
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.


Eligibility criteria: Inclusion Criteria:

* Subjects age 18 and older
* Subject (or Legal Guardian if applicable) has signed the consent form and is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits
* Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
* Stenotic, restenotic (from angioplasty only, previous treatment with drug coated balloon is not allowed) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:

  1. Degree of stenosis ≥70% by visual angiographic assessment
  2. Vessel diameter ≥ 4 and ≤ 6mm
  3. Total lesion length (or series of lesions) ≥30 mm and ≤110 mm

     * (Note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent)
  4. 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 (\<50% stenosis) to the ankle or foot

Primary outcomes:
measure: Primary Patency
timeFrame: 9-months
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With Composite of Major Adverse Events
timeFrame: 9 months
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Randwick
country: Australia
facility: Prince of Wales Hospital
city: Vienna, Austria
country: Austria
facility: Allgemeines Krankenhaus AKH
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart Tienen
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH
city: Flensburg
country: Germany
facility: Ev. Luth. Diakonissenanstalt Flensburg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Braemar Hospital
city: Otahuhu
country: New Zealand
facility: Middlemore Hospital
Study officials:
affiliation: Ev. Luth. Diakonissenanstalt Flensburg
name: Stefan Müller-Hülsbeck, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.
citation: Muller-Hulsbeck S, Keirse K, Zeller T, Schroe H, Diaz-Cartelle J. Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther. 2016 Oct;23(5):701-7. doi: 10.1177/1526602816650206. Epub 2016 May 18.