Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device..
- Who it may be relevant to
- Registry conditions: Peripheral Vascular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Canada, China +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)
Overview
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.
Interventions
- Device Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.
Ranger™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; ELUVIA™ Drug-Eluting Vascular Stent System
Primary outcome measures
- Major Adverse Events [Time frame: 12 months]
- Lesion Patency [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 52 centers
- St. Bernard's Medical Center — Jonesboro
- PIH Health Good Samaritan Hospital — Los Angeles
- Cedars - Sinai Medical Center — Los Angeles
- Ronald Reagan UCLA Medical Center — Los Angeles
- Sutter Medical Center, Sacramento — Sacramento
- Adventist Health St Helena Hospital — St. Helena
- Yale University School of Medicine — New Haven
- Christiana Hospital — Newport
- … and 44 more centers
China · 11 centers
- Beijing Anzhen Hospital of the Capital University of Medical Sciences — Chaoyang
- China-Japan Friendship Hospital — Chaoyang
- Xuanwu Hospital Capital Medical University — Xicheng
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
- Zhongshan University No.1 Hospital — Guangzhou
- Affiliated Hospital of Medical College Qingdao University — Qingdao
- Shanghai Ninth People's Hospital - Shanghai Jiaotong University School of Medicine — Huangpu
- Shanghai Changhai Hospital — Yangpu
- … and 3 more centers
Germany · 3 centers
- Fürst Stirum Klinik Bruchsal Hospital — Bruchsal
- University Clinic Essen-Hospital — Essen
- Klinikum der Ludwig-Maximilians-Universitat — München
Australia · 2 centers
- Royal Perth Hospital — Perth
- Royal North Shore Hospital — St Leonards
Canada · 2 centers
- Peter Lougheed Centre-Hospital — Calgary
- CHUS - Hotel Dieu — Sherbrooke
France · 2 centers
- Hospital Marie Lannelongue — Le Plessis-Robinson
- Hospital Paris Saint Joseph — Paris
Taiwan · 2 centers
- China Medical University Hospital — Taichung
- National Taiwan University Hospital — Taipei
Thailand · 2 centers
- Siriraj Hospital Department of Surgery — Bangkok
- Prince of Songkla University — Hat Yai
Austria · 1 center
- Medizinische Univ.-Kliniken Graz — Graz
Japan · 1 center
- Osaka Keisatsu Hospital — Osaka
Poland · 1 center
- Uniwersyteckim Szpitalem Klinicznym w Poznaniu — Poznan
Spain · 1 center
- Corporacio Sanitaria Parc Taulí, Barcelona — Sabadell
Publications
- Secemsky EA, Giri J, Brodmann M, Goueffic Y, Fu W, Greenberg-Worisek AJ, Jaff MR, Kirksey L, Kohi MP. Implementing methods in the ELEGANCE registry to increase diversity in clinical research. J Vasc Surg. 2024 Jan;79(1):136-145.e3. doi: 10.1016/j.jvs.2023.08.131. Epub 2023 Sep 22. PMID 37742734
Identifiers
NCT: NCT04674969 · S2444