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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: March 22, 2013
Last updated: April 20, 2015
Last verified: April 2015
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 Intervention Phase
Atherosclerosis of Native Arteries of the Extremities
Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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.

Other Outcome Measures:
  • 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

Enrollment: 57
Study Start Date: July 2013
Estimated Study Completion Date: March 2017
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
Herzzentrum 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
  More Information

Responsible Party: Boston Scientific Corporation Identifier: NCT01820637     History of Changes
Other Study ID Numbers: S2049 
Study First Received: March 22, 2013
Last Updated: April 20, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Austrian Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Boston Scientific Corporation:
lower extremities

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators processed this record on May 26, 2016