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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01820637
First received: March 22, 2013
Last updated: March 8, 2017
Last verified: March 2017
March 22, 2013
March 8, 2017
July 2013
December 2014   (Final data collection date for primary outcome measure)
Primary patency [ Time Frame: 9-months ]
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 ]
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
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
February 20, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Germany,   New Zealand
 
 
NCT01820637
S2049
No
Not Provided
No
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Stefan Müller-Hülsbeck, Prof. Ev. Luth. Diakonissenanstalt Flensburg
Boston Scientific Corporation
March 2017

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