A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries
NCT ID: NCT03037411
Last Updated: 2022-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
291 participants
OBSERVATIONAL
2016-12-13
2022-03-24
Brief Summary
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Detailed Description
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The objective of the study is to collect additional data including health economics data to support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ELUVIA stent implantation
Peripheral stenting
Peripheral stenting
stent implantation during the index procedure
Interventions
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Peripheral stenting
stent implantation during the index procedure
Eligibility Criteria
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Inclusion Criteria
2. Subject is willing and able to provide written consent before any study-specific test or procedure is performed and agrees to attend all follow-up visits
3. De novo, restenotic or (re)occluded lesions in the native femoro-popliteal arteries, with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment
Exclusion Criteria
2. Life expectancy of less than 1 year (which is defined as documented life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical follow-up, limit the subject's compliance with the standard of care follow-up, or impact the scientific integrity of the trial)
3. Known allergy to the ELUVIA stent system or any of its components, concomitant medication, contrast agents (that cannot be medically managed)
4. Subject enrolled in an investigational study that has not reached primary endpoint at the time of enrollment or that clinically interferes with the current study assessments (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)
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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Carlo Setacci
Role: PRINCIPAL_INVESTIGATOR
Policlinico Le Scotte, Siena
Locations
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Medizinische Universität Graz
Graz, , Austria
ZOL Genk
Genk, Limburg, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Vlaams-Brabant, Belgium
CHU Sart Tilman
Liège, , Belgium
Centre Hospitalier Universitaire Grenoble-Alpes
Grenoble, , France
Clinique Parly II
Le Chesnay, , France
ASL Asti
Asti, , Italy
Policlinico Vittorio Emanuele
Catania, , Italy
Policlinico di Monza
Monza, , Italy
Policlinico Umberto I
Roma, , Italy
L'Azienda sanitaira ASL Roma 1
Roma, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
Hospital Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Hospital Universitario de Burgos
Burgos, , Spain
Hosp. Puerta del Mar
Cadiz, , Spain
Hospital San Pedro de Alcántara
Cáceres, , Spain
Hosp . Universitario de Guadalajara
Guadalajara, , Spain
Hosp. Ntra Sra. del Rosario
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hosp. Complejo Hosp Universitario (CHUO)
Ourense, , Spain
Hospital de Montecelo (Pontevedra EOXI)
Pontevedra, , Spain
Hospital Parc Tauli
Sabadell, , Spain
Foundation for the Aragonese Healthcare Research Institute
Zaragoza, , Spain
Countries
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Other Identifiers
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S2346
Identifier Type: -
Identifier Source: org_study_id
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