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A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries (REGAL)

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ClinicalTrials.gov Identifier: NCT03037411
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Arteriosclerosis Device: Peripheral stenting

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : December 2016
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Group/Cohort Intervention/treatment
ELUVIA stent implantation
Peripheral stenting
Device: Peripheral stenting
stent implantation during the index procedure




Primary Outcome Measures :
  1. Health care costs [ Time Frame: Index Procedure, 1, 6, 12 and 24 months ]
    Health care costs at index procedure and changes in health care costs from baseline


Secondary Outcome Measures :
  1. Quality of Life Improvement [ Time Frame: 1, 6, 12 and 24 months ]
    Change in EQ-5D-5L™ from baseline

  2. Walking Improvement [ Time Frame: 1, 6, 12 and 24 months ]
    Change in Walking Impairment Questionnaire (WIQ) from baseline

  3. Rate of Primary and Secondary Sustained Clinical Improvement [ Time Frame: 1, 6, 12 and 24 months ]
    Changes in Rutherford Classification from baseline

  4. Rate of Hemodynamic Improvement [ Time Frame: 1, 6, 12 and 24 months ]
    Changes in in Ankle-Brachial Index (ABI) from baseline

  5. Health care utilization [ Time Frame: 1, 6, 12 and 24 months ]
    Changes in healthcare utilization over time


Other Outcome Measures:
  1. Technical success of the stenting procedure [ Time Frame: During stenting procedure ]
    Technical success defined as delivery and deployment of the study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually

  2. Procedural success of the stenting procedure [ Time Frame: within 24 hours of stenting procedure ]
    Procedural success defined as technical success with no MAEs noted within 24 hours of the stenting procedure

  3. Adverse Event and Major Adverse Event (MAE) rate [ Time Frame: 1, 6, 12 and 24 months ]
    Adverse Event rate and MAE rate, defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate at each time point

  4. Primary patency [ Time Frame: 6, 12 and 24 months ]
    Primary patency of target lesion assessed by duplex ultrasound as adjudicated by an independent core laboratory

  5. Clinically-driven Target Lesion Revascularization (TLR) Rate [ Time Frame: 1, 6, 12 and 24 months ]
    Target Lesion Revascularization is defined as any surgical or percutaneous intervention to the target lesion(s) after the stenting procedure

  6. Clinically-driven Target Vessel Revascularization (TVR) Rate [ Time Frame: 1, 6, 12 and 24 months ]
    Target Vessel Revascularization is defined as any surgical or percutaneous intervention to the target vessel after the stenting procedure

  7. Distribution of Rutherford Classification [ Time Frame: 1, 6, 12 and 24 months ]

    Rutherford Classification:

    0 Asymptomatic - Normal Treadmill /stress test

    1. Mild claudication - Completes treadmill exercise; ankle pressure (AP) after exercise <50mm Hg, but >25 mm Hg less than BP
    2. Moderate claudication - Between categories 1 and 3
    3. Severe claudication - Cannot complete treadmill exercise and AP after exercise <50 mm Hg
    4. Ischemic rest pain - Resting AP <40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) <30 mm Hg
    5. Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal edema - Resting AP <60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP <40 mm Hg
    6. Major tissue loss-extending above MT level - Same as Category 5



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037411


Contacts
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Contact: Evi Petro +3232900306 evi.petro@genae.com
Contact: Andrew Campbell +17639558370 andrew.campbell@bsci.com

Locations
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Austria
Medizinische Universität Graz Terminated
Graz, Austria
Belgium
ZOL Genk Recruiting
Genk, Limburg, Belgium, 3600
Contact: Herman Schroë, MD       Herman.Schroe@ZOL.BE   
Principal Investigator: Herman Schroë, MD         
Regionaal Ziekenhuis Heilig Hart Tienen Recruiting
Tienen, Vlaams-Brabant, Belgium, 3300
Contact: Koen Keirse, MD       koen.keirse@rztienen.be   
Principal Investigator: Koen Keirse, MD         
France
Centre Hospitalier Universitaire Grenoble-Alpes Recruiting
Grenoble, France
Contact: Augustin Pirvu, MD       APirvu@chu-grenoble.fr   
Principal Investigator: Augustin Pirvu, MD         
Clinique Parly II Active, not recruiting
Le Chesnay, France, 78150
Italy
ASL Asti Recruiting
Asti, Italy, 14100
Contact: Alberto Pecchio, MD       apecchio@asl.at.it   
Principal Investigator: Alberto Pecchio, MD         
Policlinico Vittorio Emanuele Recruiting
Catania, Italy
Contact: Pierfrancesco Veroux, MD       pveroux@unict.it   
Principal Investigator: Pierfrancesco Veroux, MD         
Policlinico di Monza Recruiting
Monza, Italy
Contact: Filippo Scalise, MD       filippo.scalise@policlinicodimonza.it   
Principal Investigator: Filippo Scalise, MD         
Ospedale San Camillo Forlanini Not yet recruiting
Roma, Italy, 00152
Contact: Nicola Mangialardi, MD       nikmangialardi@gmail.com   
Principal Investigator: Nicola Mangialardi, MD         
Policlinico Umberto I Recruiting
Roma, Italy, 00161
Contact: Francesco Speziale, MD       francesco.speziale@uniroma1.it   
Principal Investigator: Francesco Speziale, MD         
L'Azienda sanitaira ASL Roma 1 Recruiting
Roma, Italy, 00193
Contact: Sonia Ronchey, MD       sonia.ronchey@aslroma1.it   
Principal Investigator: Sonia Ronchey, MD         
IRCCS Policlinico San Donato Recruiting
San Donato Milanese, Italy
Contact: Giovanni Nano, MD       giovanni.nano@libero.it   
Principal Investigator: Giovanni Nano, MD         
Hospital Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Contact: Domenico Benevento, MD       d.benevento@ao-siena.toscana.it   
Principal Investigator: Domenico Benevento, MD         
Spain
Hospital Universitario de Burgos Recruiting
Burgos, Spain, 09006
Contact: Ignacio Agundez, MD       nachez1967@gmail.com   
Principal Investigator: Ignacio Agundez, MD         
Hosp. Puerta del Mar Recruiting
Cadiz, Spain
Contact: Manuel Rodriguez Piñero, MD       manuel.rodriguez.pinero.sspa@juntadeandalucia.es   
Principal Investigator: Manuel Rodriguez Piñero, MD         
Hospital San Pedro de Alcántara Recruiting
Cáceres, Spain, 10004
Contact: Javier Fernández Portales, MD       portales70@hotmail.com   
Principal Investigator: Javier Fernández Portales, MD         
Hosp . Universitario de Guadalajara Recruiting
Guadalajara, Spain, 19002
Contact: Mercedes Guerra Requena, MD       merguerra24@gmail.com   
Principal Investigator: Mercedes Guerra Requena, MD         
Hosp. Ntra Sra. del Rosario Suspended
Madrid, Spain, 28006
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Isaac Martinez Lopez, MD       isaacml20@hotmail.com   
Principal Investigator: Isaac Martinez Lopez, MD         
Hospital Universitario Severo Ochoa Recruiting
Madrid, Spain, 28911
Contact: Jose Maria Abadal, MD       jmabadal@yahoo.es   
Principal Investigator: Jose Maria Abadal, MD         
Hosp. Complejo Hosp Universitario (CHUO) Recruiting
Ourense, Spain
Contact: Nilo Mosquera, MD       nmarochena@me.com   
Principal Investigator: Nilo Mosquera, MD         
Hospital de Montecelo (Pontevedra EOXI) Active, not recruiting
Pontevedra, Spain, 30071
Hospital Parc Tauli Recruiting
Sabadell, Spain
Contact: Antoni Gimenez Gaibar, MD       agimenezg@tauli.cat   
Principal Investigator: Antoni Gimenez Gaibar, MD         
Foundation for the Aragonese Healthcare Research Institute Recruiting
Zaragoza, Spain, 50009
Contact: José Manuel Buisan-Bardaij         
Principal Investigator: José Manuel Buisan-Bardaij, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Carlo Setacci Policlinico Le Scotte, Siena

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03037411     History of Changes
Other Study ID Numbers: S2346
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Boston Scientific Corporation:
Atherosclerosis
Superficial Femoral Artery (SFA)
Proximal Popliteal Artery (PPA)
Stenting
Paclitaxel
Health Economics

Additional relevant MeSH terms:
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Atherosclerosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases