Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)

September 11, 2026 updated by: Boston Scientific Corporation

Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
      • St Leonards, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
        • Principal Investigator:
          • Vikram Puttaswamy
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Royal Perth Hospital
        • Principal Investigator:
          • Nishath Altaf
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medizinische Univ.-Kliniken Graz
        • Principal Investigator:
          • Marianne Brodmann
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • Peter Lougheed Centre-Hospital
        • Principal Investigator:
          • Ani Mirakhur
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
        • Active, not recruiting
        • CHUS - Hotel Dieu
  • China
    • Beijing Municipality
      • Chaoyang, Beijing Municipality, China
        • Active, not recruiting
        • Beijing Anzhen Hospital of the Capital University of Medical Sciences
      • Chaoyang, Beijing Municipality, China
        • Active, not recruiting
        • China-Japan Friendship Hospital
      • Xicheng, Beijing Municipality, China
        • Active, not recruiting
        • Xuanwu Hospital Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Active, not recruiting
        • The First Affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Active, not recruiting
        • Zhongshan University No.1 Hospital
    • Shandong
      • Qingdao, Shandong, China
        • Active, not recruiting
        • Affiliated Hospital of Medical College Qingdao University
    • Shanghai Municipality
      • Huangpu, Shanghai Municipality, China
        • Active, not recruiting
        • Shanghai Ninth People's Hospital - Shanghai Jiaotong University School of Medicine
      • Yangpu, Shanghai Municipality, China
        • Active, not recruiting
        • Shanghai Changhai Hospital
    • Shanxi
      • Taiyuan, Shanxi, China
        • Active, not recruiting
        • Shanxi Bethune Hospital
      • Xi’an, Shanxi, China
        • Active, not recruiting
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
    • Xuhui District
      • Shanghai, Xuhui District, China
        • Active, not recruiting
        • Shanghai Zhongshan Hospital
  • France
      • Le Plessis-Robinson, France, 92350
        • Active, not recruiting
        • Hospital Marie Lannelongue
      • Paris, France
        • Recruiting
        • Hospital Paris Saint Joseph
        • Principal Investigator:
          • Yann Goueffic
  • Germany
      • Bruchsal, Germany
        • Recruiting
        • Fürst Stirum Klinik Bruchsal Hospital
        • Principal Investigator:
          • Martin Andrassy
      • Essen, Germany
        • Recruiting
        • University Clinic Essen-Hospital
        • Principal Investigator:
          • Christos Rammos
      • München, Germany
        • Recruiting
        • Klinikum der Ludwig-Maximilians-Universitat
        • Principal Investigator:
          • Konstantinos Stavroulakis
  • Japan
      • Aichi, Japan, 461-0045
        • Recruiting
        • Nagoya Heart Center
        • Principal Investigator:
          • Takahiro Tokuda
      • Chiba, Japan, 289-2511
        • Recruiting
        • Asahi General Hospital
        • Principal Investigator:
          • Naoki Hayakawa
      • Osaka, Japan, 543-8922
        • Recruiting
        • Osaka Keisatsu Hospital
        • Principal Investigator:
          • Osamu Iida
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 007-0849
        • Recruiting
        • Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
        • Principal Investigator:
          • Takuya Haraguchi
  • Poland
      • Poznan, Poland, 60-355
        • Recruiting
        • Uniwersyteckim Szpitalem Klinicznym w Poznaniu
        • Principal Investigator:
          • Zbigniew Krasinski
  • Spain
      • Sabadell, Spain
        • Recruiting
        • Corporacio Sanitaria Parc Taulí, Barcelona
        • Principal Investigator:
          • Marta Santos
  • Taiwan
      • Taichung, Taiwan, 40408
        • Recruiting
        • China Medical University Hospital
        • Principal Investigator:
          • Chung-Ho Hsu
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Jen-Kuang Lee
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital Department of Surgery
        • Principal Investigator:
          • Nattawut Puangpunngam
      • Hat Yai, Thailand, 90110
        • Recruiting
        • Prince of Songkla University
        • Principal Investigator:
          • Sorracha Rookkapan
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • St. Bernard's Medical Center
        • Principal Investigator:
          • Max Arroyo
    • California
      • Los Angeles, California, United States, 90017
        • Recruiting
        • PIH Health Good Samaritan Hospital
        • Principal Investigator:
          • Guy Mayeda
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars - Sinai Medical Center
        • Principal Investigator:
          • Suhail Dohad
      • Los Angeles, California, United States, 90095
        • Withdrawn
        • Ronald Reagan UCLA Medical Center
      • Sacramento, California, United States, 95816
        • Completed
        • Sutter Medical Center, Sacramento
      • St. Helena, California, United States, 94574
        • Recruiting
        • Adventist Health St Helena Hospital
        • Principal Investigator:
          • Leonardo Clavijo
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School Of Medicine
        • Principal Investigator:
          • Cassius Ochoa Chaar
    • Delaware
      • Newport, Delaware, United States, 19718
        • Recruiting
        • Christiana Hospital
        • Principal Investigator:
          • Daniel Leung
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Washington Hospital Center
        • Principal Investigator:
          • Nelson Bernardo
    • Florida
      • Boynton Beach, Florida, United States, 33436
        • Withdrawn
        • Palm Beach Heart & Vascular, LLC
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Tallahassee Memorial Hospital
        • Principal Investigator:
          • William Dixon
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University Hospital
        • Principal Investigator:
          • Manuel Garcia-Toca
      • Valdosta, Georgia, United States, 31602
        • Recruiting
        • South Georgia Medical Center
        • Principal Investigator:
          • David Hardy
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University
        • Principal Investigator:
          • Kumar Madassery
      • Springfield, Illinois, United States, 62701
        • Recruiting
        • St. John's Hospital/ Prairie Education and Research Cooperative
        • Principal Investigator:
          • Avinash Murthy
    • Indiana
      • Fort Wayne, Indiana, United States, 46774
        • Withdrawn
        • St. Joseph Hospital/Dupont Hospital
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St. Vincent's Hospital
        • Principal Investigator:
          • Kannan Natarajan
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Completed
        • CIS Clinical Research Corporation
      • Kenner, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Principal Investigator:
          • George Yousef
      • Lafayette, Louisiana, United States, 70506
        • Withdrawn
        • Cardiovascular Institute of the South
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Eric Secemsky
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55432
        • Active, not recruiting
        • Mercy Hospital (Allina Health)
    • Mississippi
      • Tupelo, Mississippi, United States, 38804
        • Recruiting
        • North Mississippi Medical Center
        • Principal Investigator:
          • Barry Bertolet
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Active, not recruiting
        • Deborah Heart & Lung Center
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • David O'Connor
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Principal Investigator:
          • John Shao
    • New York
      • Buffalo, New York, United States, 55313
        • Recruiting
        • Buffalo General Hospital
        • Principal Investigator:
          • Sonya Noor
      • Manhasset, New York, United States, 11030
        • Active, not recruiting
        • North Shore University Hospital/Northwell Health
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai
        • Principal Investigator:
          • Kirema Garcia-Reyes
      • New York, New York, United States, 10027
        • Recruiting
        • Columbia University
        • Principal Investigator:
          • Sahil Parikh
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Medical Center
        • Principal Investigator:
          • Anvar Babaev
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Hospital
        • Principal Investigator:
          • Yolanda Bryce
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine/New York-Presbyterian Hospital
        • Principal Investigator:
          • Brian DeRubertis
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Chandler Long
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Rex UNC Health (NC Heart and Vascular Research, LLC)
        • Principal Investigator:
          • Ravish Sachar
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Sean Lyden
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals of Cleveland
        • Principal Investigator:
          • Jun Li
      • Dayton, Ohio, United States, 45409
        • Completed
        • Premier Cardiovascular Institute
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Ascension St. John Clinical Research Institute
        • Principal Investigator:
          • Nicholas Hanna
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17043
        • Completed
        • Pinnacle Health Cardiovascular Institute
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
          • Dawn Salvatore
        • Principal Investigator:
          • Dawn Salvatore
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital University of Pennsylvania
        • Principal Investigator:
          • Grace Wang
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • The Miriam Hospital
        • Principal Investigator:
          • Peter Soukas
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Active, not recruiting
        • Medical University of South Carolina
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Completed
        • Monument Health Rapid City Hospital, Inc.
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Seton Medical Center
        • Principal Investigator:
          • Peter Monteleone
      • Dallas, Texas, United States, 75390
        • Recruiting
        • The University of Texas, Southwestern Medical Center
        • Principal Investigator:
          • Michael Siah
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Jayer Chung
      • Lubbock, Texas, United States, 79430
        • Completed
        • Texas Tech University Health Sciences Center
      • Plano, Texas, United States, 75075
        • Recruiting
        • HeartPlace P.A.
        • Principal Investigator:
          • Vijay Ramanath
    • Virginia
      • Fairfax, Virginia, United States, 22042
        • Recruiting
        • INOVA Fairfax Hospital
        • Principal Investigator:
          • Jonathan Keung
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • UW Medicine - Harborview Medical Center
        • Principal Investigator:
          • Elina Quiroga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Outcomes Cohort
Patients at select sites will complete the Clinical Cohort standard of care assessments and additional assessments as part of the Outcomes Cohort, including Quality of Life questionnaires, six-minute walk test (6MWT), and Healthcare Utilization data collection.
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
Clinical Cohort
All enrolled patients are included in the Clinical Cohort. Patients will complete assessments per standard of care through 2-year follow-up in Australia, Austria, Canada, France, Germany, Poland, Spain, Taiwan, Thailand, and the United States. Patients will complete assessments per standard of care through 5-year follow-up in China.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major Adverse Events
Time Frame: 12 months
Rate of MAEs, which include Target Lesion Revascularizations, Major Target Limb Amputations, and Deaths. No pre-specified endpoints or formal tests of hypotheses are proposed. Analyses will be performed for exploratory purposes.
12 months
Lesion Patency
Time Frame: 12 months
Lesion patency is determined by Duplex Ultrasound (Investigator and/or Core Lab assessed) and freedom from clinically-driven Target Lesion Revascularization. No pre-specified endpoints or formal tests of hypotheses are proposed. Analyses will be performed for exploratory purposes.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S2444

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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