A Randomized Trial Comparing the ELUVIA Drug-eluting Stent Versus Bare Metal Self-expanding Nitinol Stents in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

Status: Completed
Location: See all (60) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects age 18 and older

• Subject is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits

• Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4

• Stenotic, restenotic or occlusive lesion(s) located in the native Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA):

‣ Degree of stenosis ≥ 70 % by visual angiographic assessment

⁃ Vessel diameter ≥ 4 and ≤ 6 mm

⁃ Total lesion length (or series of lesions) ≥ 30 mm and ≤210 mm (Note: Lesion segment(s) must be fully covered with one or two overlapping ELUVIA stent(s) or Self Expanding Bare Nitinol stent(s))

⁃ For occluded lesions (chronic occlusions) requiring use of re-entry device, lesion length ≤ 180 mm

⁃ 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 with no planned intervention

Locations
Other Locations
Austria
LKH Innsbruck
Innsbruck
Klinikum Klagenfurt
Klagenfurt
Allgemeines Krankenhaus Wien
Vienna
Belgium
OLV Aalst
Aalst
ZiekenhuisNetwerk Antwerpen
Antwerp
Imelda Hospital
Bonheiden
AZ Sint-Blasius
Dendermonde
UZ Antwerpen
Edegem
UZ Gent
Ghent
UZ Leuven
Leuven
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen
France
Hopital Privé Paul D'Egine
Champigny-sur-marne
CHU - Hopital Gabriel Montpied
Clermont-ferrand
L'Hôpital Henri-Mondor
Créteil
CHU Dijon
Dijon
CHU Lille
Lille
Hopital Edouard Herriot
Lyon
CHU Nancy
Nancy
Hopital Nord Laennec
Nantes
(Hôpital Européen Georges-Pompidou
Paris
CH de Saint-Nazaire
Saint-nazaire
CHU Strasbourg
Strasbourg
Clinique Pasteur
Toulouse
CH Valenciennes
Valenciennes
Germany
Universitäts Herzzentrum
Bad Krozingen
Sankt Gertrauden-Krankenhaus
Berlin
Universitätsklinikum Bonn
Bonn
Universitätsklinikum Essen
Essen
Krankenhäuser Landkreis Freudenstadt GmbH
Freudenstadt
Universitätsklinikum Heidelberg
Heidelberg
SRH Klinikum Karlsbad-Langensteinbach
Karlsbad
University Hospital Schleswig-Holstein Campus Kiel
Kiel
University Medical Center of Johannes Gutenberg-Mainz
Mainz
Universitätsklinikum Marburg
Marburg
Klinik Diakoniewerk München-Maxvorstadt
München
St. Franziskus-Hospital Muenster
Münster
Universitätsklinikum Münster
Münster
Krankenhaus Barmherzige Brüder
Regensburg
RoMed Klinikum Rosenheim
Rosenheim
MEDINOS Kliniken Sonneberg GmbH
Sonneberg
Krankenhaus Torgau
Torgau
University Hospital of Tübingen
Tübingen
Klinikum Nordoberpfalz AG, Klinikum Weiden
Weiden
Ireland
Beaumont Hospital
Dublin
Italy
Centro cardiologico Monzino
Milan
San Raffaele Hospital
Milan
Ospedaliero Universitaria Federico II
Naples
Netherlands
Hagaziekenhuis
The Hague
Elisabeth Tilburg Ziekenhuis
Tilburg
Spain
Hospital Virgen Macarena
Seville
Switzerland
Inselspital Bern
Bern
Kantonsspital Luzern
Lucerne
United Kingdom
Royal Bournemouth Hospital
Bournemouth
Addenbrookes Hospital
Cambridge
Royal London Hospital
London
St. Mary's Hospital
London
St.Thomas' Hospital
London
Manchester University NHS Foundation Trust
Manchester
Freeman Hospital
Newcastle Upon Tyne
Nottingham University Hospital
Nottingham
Time Frame
Start Date: 2016-10-25
Completion Date: 2023-11-06
Participants
Target number of participants: 775
Treatments
Experimental: ELUVIA Stent Implantation
Peripheral stenting
Active_comparator: control Bare Metal Stent Implantation
Peripheral stenting
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov