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
  Purpose

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
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820637

Locations
Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Prince of Wales Hospital
Randwick, Australia
Austria
Allgemeines Krankenhaus AKH
Vienna, Austria, Austria
Belgium
AZ Sint-Blasius
Dendermonde, Belgium, 9200
Ziekenhuis Oost Limburg
Genk, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Belgium, 3300
Germany
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
Investigators
Principal Investigator: Stefan Müller-Hülsbeck, Prof. Ev. Luth. Diakonissenanstalt Flensburg
  More Information

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01820637     History of Changes
Other Study ID Numbers: S2049
Study First Received: March 22, 2013
Last Updated: March 17, 2014
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:
atherosclerosis
SFA
PPA
lower extremities
stenting
paclitaxel

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014