Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project
NCT ID: NCT01820637
Last Updated: 2019-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2013-08-23
2017-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Drug-eluting SFA self-expanding stent
Interventions
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The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Drug-eluting SFA self-expanding stent
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Stefan Müller-Hülsbeck, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ev. Luth. Diakonissenanstalt Flensburg
Locations
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Royal Prince Alfred Hospital
Camperdown, , Australia
Prince of Wales Hospital
Randwick, , Australia
Allgemeines Krankenhaus AKH
Vienna, Austria, , Austria
AZ Sint-Blasius
Dendermonde, , Belgium
Ziekenhuis Oost Limburg
Genk, , Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, , Belgium
Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH
Bad Krozingen, , Germany
Ev. Luth. Diakonissenanstalt Flensburg
Flensburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universität Leipzig
Leipzig, , Germany
Auckland City Hospital
Auckland, , New Zealand
Braemar Hospital
Hamilton, , New Zealand
Middlemore Hospital
Otahuhu, , New Zealand
Countries
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References
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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.
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.
Other Identifiers
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S2049
Identifier Type: -
Identifier Source: org_study_id
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