Clinical trial NCT03037411: A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries
Official title: A Real World Evaluation of the ELUVIA Drug Eluting Stent in All-Comers With Superficial Femoral Artery and Proximal Popliteal Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Arteriosclerosis
Keywords: Atherosclerosis
Superficial Femoral Artery (SFA)
Proximal Popliteal Artery (PPA)
Stenting
Paclitaxel
Health Economics
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Intended population for the REGAL study are 'real world'-patients with symptomatic de-novo, restenotic, or (re)occluded lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment.

Brief summary: The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.

Detailed description: A European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects age 18 and older
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:

1. Subject is pregnant or planning to become pregnant during the course of the study
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)

Primary outcomes:
measure: Health care costs
timeFrame: Index Procedure, 1, 6, 12 and 24 months
Secondary outcomes:
measure: Quality of Life Improvement
timeFrame: 1, 6, 12 and 24 months
measure: Walking Improvement
timeFrame: 1, 6, 12 and 24 months
measure: Rate of Primary and Secondary Sustained Clinical Improvement
timeFrame: 1, 6, 12 and 24 months
measure: Rate of Hemodynamic Improvement
timeFrame: 1, 6, 12 and 24 months
measure: Health care utilization
timeFrame: 1, 6, 12 and 24 months
Other outcomes:
measure: Technical success of the stenting procedure
timeFrame: During stenting procedure
measure: Procedural success of the stenting procedure
timeFrame: within 24 hours of stenting procedure
measure: Adverse Event and Major Adverse Event (MAE) rate
timeFrame: 1, 6, 12 and 24 months
measure: Primary patency
timeFrame: 6, 12 and 24 months
measure: Clinically-driven Target Lesion Revascularization (TLR) Rate
timeFrame: 1, 6, 12 and 24 months
measure: Clinically-driven Target Vessel Revascularization (TVR) Rate
timeFrame: 1, 6, 12 and 24 months
measure: Distribution of Rutherford Classification
timeFrame: 1, 6, 12 and 24 months
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Genk
country: Belgium
facility: ZOL Genk
state: Limburg
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart Tienen
state: Vlaams-Brabant
city: Liège
country: Belgium
facility: CHU Sart Tilman
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble-Alpes
city: Le Chesnay
country: France
facility: Clinique Parly II
city: Asti
country: Italy
facility: ASL Asti
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele
city: Monza
country: Italy
facility: Policlinico di Monza
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Roma
country: Italy
facility: L'Azienda sanitaira ASL Roma 1
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Siena
country: Italy
facility: Hospital Azienda Ospedaliera Universitaria Senese
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cadiz
country: Spain
facility: Hosp. Puerta del Mar
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Guadalajara
country: Spain
facility: Hosp . Universitario de Guadalajara
city: Madrid
country: Spain
facility: Hosp. Ntra Sra. del Rosario
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Ourense
country: Spain
facility: Hosp. Complejo Hosp Universitario (CHUO)
city: Pontevedra
country: Spain
facility: Hospital de Montecelo (Pontevedra EOXI)
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
city: Zaragoza
country: Spain
facility: Foundation for the Aragonese Healthcare Research Institute
Study officials:
affiliation: Policlinico Le Scotte, Siena
name: Carlo Setacci
role: PRINCIPAL_INVESTIGATOR
References: