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

December 18, 2018 updated by: Boston Scientific Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia
        • Royal Prince Alfred Hospital
      • Randwick, Australia
        • Prince of Wales Hospital
  • Austria
      • Vienna, Austria, Austria
        • Allgemeines Krankenhaus AKH
  • Belgium
      • Dendermonde, Belgium, 9200
        • AZ Sint-Blasius
      • Genk, Belgium
        • Ziekenhuis Oost Limburg
      • Tienen, Belgium, 3300
        • Regionaal Ziekenhuis Heilig Hart Tienen
  • Germany
      • Bad Krozingen, Germany
        • Universitats-Herzzentrum Freiburg Bad Krozingen GmbH
      • Flensburg, Germany
        • Ev. Luth. Diakonissenanstalt Flensburg
      • Heidelberg, Germany
        • Universitatsklinikum Heidelberg
      • Leipzig, Germany
        • Universität Leipzig
  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
      • Hamilton, New Zealand
        • Braemar Hospital
      • Otahuhu, New Zealand
        • Middlemore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Patency
Time Frame: 9-months
Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.
9-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Composite of Major Adverse Events
Time Frame: 9 months
The composite rate of Major Adverse Events (MAEs) is defined as all causes of death through 1 month, target limb major amputation through 9 months and/or target lesion revascularization through 9 months.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Stefan Müller-Hülsbeck, Prof., Ev. Luth. Diakonissenanstalt Flensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 23, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

February 20, 2017

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (ESTIMATE)

March 29, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2019

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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