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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01820637
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment
Atherosclerosis of Native Arteries of the Extremities Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project With Boston Scientific's Innova Drug Eluting Stent
Actual Study Start Date : July 2013
Primary Completion Date : December 2014
Study Completion Date : February 20, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
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)
Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Drug-eluting SFA self-expanding stent

Primary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01820637

Royal Prince Alfred Hospital
Camperdown, Australia
Prince of Wales Hospital
Randwick, Australia
Allgemeines Krankenhaus AKH
Vienna, Austria, Austria
AZ Sint-Blasius
Dendermonde, Belgium, 9200
Ziekenhuis Oost Limburg
Genk, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Belgium, 3300
Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH
Bad Krozingen, Germany
Ev. Luth. Diakonissenanstalt Flensburg
Flensburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universität Leipzig
Leipzig, Germany
New Zealand
Auckland City Hospital
Auckland, New Zealand
Braemar Hospital
Hamilton, New Zealand
Middlemore Hospital
Otahuhu, New Zealand
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Stefan Müller-Hülsbeck, Prof. Ev. Luth. Diakonissenanstalt Flensburg

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation Identifier: NCT01820637     History of Changes
Other Study ID Numbers: S2049
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston Scientific Corporation:
lower extremities

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action