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

Primary Purpose

Atherosclerosis of Native Arteries of the Extremities

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis of Native Arteries of the Extremities focused on measuring atherosclerosis, SFA, PPA, lower extremities, stenting, paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Prince Alfred Hospital
  • Prince of Wales Hospital
  • Allgemeines Krankenhaus AKH
  • AZ Sint-Blasius
  • Ziekenhuis Oost Limburg
  • Regionaal Ziekenhuis Heilig Hart Tienen
  • Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH
  • Ev. Luth. Diakonissenanstalt Flensburg
  • Universitätsklinikum Heidelberg
  • Universität Leipzig
  • Auckland City Hospital
  • Braemar Hospital
  • Middlemore Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test device arm (DES SFA)

Arm Description

Patients in this arm will receive the study device: the Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)

Outcomes

Primary Outcome Measures

Primary Patency
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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2013
Last Updated
December 18, 2018
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01820637
Brief Title
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
Acronym
MAJESTIC
Official Title
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project With Boston Scientific's Innova Drug Eluting Stent
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 23, 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis of Native Arteries of the Extremities
Keywords
atherosclerosis, SFA, PPA, lower extremities, stenting, paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test device arm (DES SFA)
Arm Type
Experimental
Arm Description
Patients in this arm will receive the study device: the Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Intervention Type
Device
Intervention Name(s)
The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Intervention Description
Drug-eluting SFA self-expanding stent
Primary Outcome Measure Information:
Title
Primary Patency
Description
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.
Time Frame
9-months
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Composite of Major Adverse Events
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Müller-Hülsbeck, Prof.
Organizational Affiliation
Ev. Luth. Diakonissenanstalt Flensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
Country
Australia
Facility Name
Allgemeines Krankenhaus AKH
City
Vienna, Austria
Country
Austria
Facility Name
AZ Sint-Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
Ziekenhuis Oost Limburg
City
Genk
Country
Belgium
Facility Name
Regionaal Ziekenhuis Heilig Hart Tienen
City
Tienen
ZIP/Postal Code
3300
Country
Belgium
Facility Name
Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH
City
Bad Krozingen
Country
Germany
Facility Name
Ev. Luth. Diakonissenanstalt Flensburg
City
Flensburg
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universität Leipzig
City
Leipzig
Country
Germany
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Braemar Hospital
City
Hamilton
Country
New Zealand
Facility Name
Middlemore Hospital
City
Otahuhu
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21953370
Citation
Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.
Results Reference
background
PubMed Identifier
27193308
Citation
Muller-Hulsbeck S, Keirse K, Zeller T, Schroe H, Diaz-Cartelle J. Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther. 2016 Oct;23(5):701-7. doi: 10.1177/1526602816650206. Epub 2016 May 18.
Results Reference
derived

Learn more about this trial

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

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