Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project (MAJESTIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01820637
First received: March 22, 2013
Last updated: March 17, 2014
Last verified: March 2014

March 22, 2013
March 17, 2014
July 2013
December 2014   (final data collection date for primary outcome measure)
Primary patency [ Time Frame: 9-months ] [ Designated as safety issue: Yes ]
Primary patency of target lesion at 9-months assessed by duplex ultrasound as adjudicated by an independent core laboratory.
Same as current
Complete list of historical versions of study NCT01820637 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
MAE rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 9 months and/or target lesion revascularization through 9 months
Same as current
 
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project With Boston Scientific's Innova Drug Eluting Stent

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atherosclerosis of Native Arteries of the Extremities
Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Drug-eluting SFA self-expanding stent
Experimental: Test device arm (DES SFA)
Patients in this arm will receive the study device: the Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Intervention: Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
57
March 2017
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   New Zealand,   Belgium,   Germany,   Australia
 
NCT01820637
S2049
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Stefan Müller-Hülsbeck, Prof. Ev. Luth. Diakonissenanstalt Flensburg
Boston Scientific Corporation
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP