Skip to main content
OpenTrials
Completed

NCT Number: NCT01820637

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atherosclerosis of Native Arteries of the Extremities Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Camperdown, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Degree of stenosis ≥70% by visual angiographic assessment
  • Vessel diameter ≥ 4 and ≤ 6mm
  • 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)
  • 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

Treatment and study plan

The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)

Device

Drug-eluting SFA self-expanding stent

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project With Boston Scientific's Innova Drug Eluting Stent

Acronym: MAJESTIC

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Mar 29, 2013
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.