Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01820637




Registration number
NCT01820637
Ethics application status
Date submitted
22/03/2013
Date registered
29/03/2013
Date last updated
22/03/2019

Titles & IDs
Public title
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
Scientific title
Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project With Boston Scientific's Innova Drug Eluting Stent
Secondary ID [1] 0 0
S2049
Universal Trial Number (UTN)
Trial acronym
MAJESTIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis of Native Arteries of the Extremities 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)

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)


Treatment: Devices: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Drug-eluting SFA self-expanding stent
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Patency
Timepoint [1] 0 0
9-months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/02/2017
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna, Austria
Country [2] 0 0
Belgium
State/province [2] 0 0
Dendermonde
Country [3] 0 0
Belgium
State/province [3] 0 0
Genk
Country [4] 0 0
Belgium
State/province [4] 0 0
Tienen
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Krozingen
Country [6] 0 0
Germany
State/province [6] 0 0
Flensburg
Country [7] 0 0
Germany
State/province [7] 0 0
Heidelberg
Country [8] 0 0
Germany
State/province [8] 0 0
Leipzig
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Hamilton
Country [11] 0 0
New Zealand
State/province [11] 0 0
Otahuhu

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01820637
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Stefan Müller-Hülsbeck, Prof.
Address 0 0
Ev. Luth. Diakonissenanstalt Flensburg
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01820637