Clinical trial NCT04674969: Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
Official title: Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Vascular Diseases
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 5000
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 ELEGANCE Registry are real-world patients who are treated with commercially available BSC drug-eluting devices marketed for treatment of lesions located in the peripheral vasculature. Efforts will be made to include study centers with diverse patient populations in order to enroll populations previously not represented in PVD trials.

Brief summary: The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

Detailed description: A global prospective, non-randomized, open-label, multi-center Registry to collect Real-World Data, including health economic data, to support the use of commercially available drug-eluting BSC devices for the treatment of lesions located in the peripheral vasculature.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years and older
* Written informed consent (patient data release-form)
* Use of any commercially available Boston Scientific drug-eluting device marketed for treatment of lesions in the peripheral vasculature and specified in the Registry Enrollment Guide

Exclusion Criteria:

* Life expectancy of \<1 year

Primary outcomes:
measure: Major Adverse Events
timeFrame: 12 months
measure: Lesion Patency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Los Angeles
country: United States
facility: PIH Health Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars - Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center, Sacramento
state: California
city: Saint Helena
country: United States
facility: Adventist Health St Helena Hospital
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Newport
country: United States
facility: Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Boynton Beach
country: United States
facility: Palm Beach Heart & Vascular, LLC
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Valdosta
country: United States
facility: South Georgia Medical Center
state: Georgia
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital/ Prairie Education and Research Cooperative
state: Illinois
city: Fort Wayne
country: United States
facility: St. Joseph Hospital/Dupont Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Ascension St. Vincent's Hospital
state: Indiana
city: Houma
country: United States
facility: CIS Clinical Research Corporation
state: Louisiana
city: Kenner
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Lafayette
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Coon Rapids
country: United States
facility: Mercy Hospital (Allina Health)
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Brown Mills
country: United States
facility: Deborah Heart & Lung Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital/Northwell Health
state: New York
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine/New York-Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Rex UNC Health (NC Heart and Vascular Research, LLC)
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Dayton
country: United States
facility: Premier Cardiovascular Institute
state: Ohio
city: Tulsa
country: United States
facility: Ascension St. John Clinical Research Institute
state: Oklahoma
city: Harrisburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Rapid City Hospital, Inc.
state: South Dakota
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Dallas
country: United States
facility: The University of Texas, Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Plano
country: United States
facility: HeartPlace P.A.
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: UW Medicine - Harborview Medical Center
state: Washington
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
city: Graz
country: Austria
facility: Medizinische Univ.-Kliniken Graz
city: Calgary
country: Canada
facility: Peter Lougheed Centre-Hospital
state: Alberta
city: Sherbrooke
country: Canada
facility: CHUS - Hotel Dieu
state: Quebec
city: Chaoyang
country: China
facility: Beijing Anzhen Hospital of the Capital University of Medical Sciences
state: Beijing
city: Chaoyang
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Xicheng
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Zhongshan University No.1 Hospital
state: Guangdong
city: Qingdao
country: China
facility: Affiliated Hospital of Medical College Qingdao University
state: Shandong
city: Huangpu
country: China
facility: Shanghai Ninth People's Hospital - Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Yangpu
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
state: Shanxi
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Xuhui District
city: Le Plessis-Robinson
country: France
facility: Hospital Marie Lannelongue
city: Paris
country: France
facility: Hospital Paris Saint Joseph
city: Bruchsal
country: Germany
facility: Fürst Stirum Klinik Bruchsal Hospital
city: Essen
country: Germany
facility: University Clinic Essen-Hospital
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitat
city: Poznań
country: Poland
facility: Uniwersyteckim Szpitalem Klinicznym w Poznaniu
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Taulí, Barcelona
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital Department of Surgery
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
Study officials:
References: