Peripheral Vascular DiseasesELEGANCENCT04674969
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
An observational study of Peripheral Vascular Diseases, run by Boston Scientific Corporation at 86 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 86 sitesin 12 countries
- Study dates
- 29 Mar 2021to Jan 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Life expectancy of <1 year
Trial locations and contacts
86 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
86 sites in 12 countries
United States53 sites, 39 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30303
Manuel Garcia-Toca
- Recruiting
Seton Medical Center
Austin, Texas, 78705
Peter Monteleone
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Eric Secemsky
- Withdrawn
Palm Beach Heart & Vascular, LLC
Boynton Beach, Florida, 33436
- Active, not recruiting
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015
- Recruiting
Buffalo General Hospital
Buffalo, New York, 55313
Sonya Noor
- Active, not recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Rush University
Chicago, Illinois, 60612
Kumar Madassery
- Recruiting
Morton Plant Mease Healthcare System
Clearwater, Florida, 33756
Parag Patel
- Recruiting
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Jun Li
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Sean Lyden
- Active, not recruiting
Mercy Hospital (Allina Health)
Coon Rapids, Minnesota, 55432
- Recruiting
The University of Texas, Southwestern Medical Center
Dallas, Texas, 75390
Michael Siah
- Completed
Premier Cardiovascular Institute
Dayton, Ohio, 45409
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Chandler Long
- Recruiting
Inova Fairfax Hospital
Fairfax, Virginia, 22042
Jonathan Keung
- Withdrawn
St. Joseph Hospital/Dupont Hospital
Fort Wayne, Indiana, 46774
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
David O'Connor
- Completed
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17043
- Completed
CIS Clinical Research Corporation
Houma, Louisiana, 70360
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Jayer Chung
- Recruiting
Ascension St. Vincent's Hospital
Indianapolis, Indiana, 46260
Kannan Natarajan
- Recruiting
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401
Max Arroyo
- Recruiting
Ochsner Clinic Foundation
Kenner, Louisiana, 70121
George Yousef
- Withdrawn
Cardiovascular Institute of the South
Lafayette, Louisiana, 70506
- Recruiting
PIH Health Good Samaritan Hospital
Los Angeles, California, 90017
Guy Mayeda
- Recruiting
Cedars - Sinai Medical Center
Los Angeles, California, 90048
Suhail Dohad
- Withdrawn
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
- Completed
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
- Active, not recruiting
North Shore University Hospital/Northwell Health
Manhasset, New York, 11030
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06510
Cassius Ochoa Chaar
- Recruiting
New York University Medical Center
New York, New York, 10016
Anvar Babaev
- Recruiting
Columbia University
New York, New York, 10027
Sahil Parikh
- Recruiting
Mount Sinai
New York, New York, 10029
Kirema Garcia-Reyes
- Recruiting
Memorial Sloan Kettering Hospital
New York, New York, 10065
Yolanda Bryce
- Recruiting
Weill Cornell Medicine/New York-Presbyterian Hospital
New York, New York, 10065
Brian DeRubertis
- Recruiting
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
John Shao
- Recruiting
Christiana Hospital
Newport, Delaware, 19718
Daniel Leung
- Recruiting
Hospital University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Grace Wang
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Dawn Salvatore
Dawn Salvatore
- Recruiting
HeartPlace P.A.
Plano, Texas, 75075
Vijay Ramanath
- Recruiting
The Miriam Hospital
Providence, Rhode Island, 02906
Pieter de Klerk
- Recruiting
Rex UNC Health (NC Heart and Vascular Research, LLC)
Raleigh, North Carolina, 27607
Ravish Sachar
- Completed
Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota, 57701
- Completed
Sutter Medical Center, Sacramento
Sacramento, California, 95816
- Recruiting
UW Medicine - Harborview Medical Center
Seattle, Washington, 98104
Elina Quiroga
- Recruiting
St. John's Hospital/ Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Avinash Murthy
- Recruiting
Adventist Health St Helena Hospital
St. Helena, California, 94574
Leonardo Clavijo
- Recruiting
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
William Dixon
- Recruiting
Ascension St. John Clinical Research Institute
Tulsa, Oklahoma, 74104
Nicholas Hanna
- Recruiting
North Mississippi Medical Center
Tupelo, Mississippi, 38804
Barry Bertolet
- Recruiting
South Georgia Medical Center
Valdosta, Georgia, 31602
David Hardy
- Recruiting
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Nelson Bernardo
China11 sites
- Active, not recruiting
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Chaoyang, Beijing Municipality
- Active, not recruiting
China-Japan Friendship Hospital
Chaoyang, Beijing Municipality
- Active, not recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
- Active, not recruiting
Zhongshan University No.1 Hospital
Guangzhou, Guangdong
- Active, not recruiting
Shanghai Ninth People's Hospital - Shanghai Jiaotong University School of Medicine
Huangpu, Shanghai Municipality
- Active, not recruiting
Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong
- Active, not recruiting
Shanghai Zhongshan Hospital
Shanghai, Xuhui District
- Active, not recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
- Active, not recruiting
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi’an, Shanxi
- Active, not recruiting
Xuanwu Hospital Capital Medical University
Xicheng, Beijing Municipality
- Active, not recruiting
Shanghai Changhai Hospital
Yangpu, Shanghai Municipality
Japan6 sites, 6 recruiting
- Recruiting
Nagoya Heart Center
Aichi, 461-0045
Takahiro Tokuda
- Recruiting
Asahi General Hospital
Chiba, 289-2511
Naoki Hayakawa
- Recruiting
Rakuwakai Otowa Hospital
Kyoto, Kyoto, 607-8062
Takashi Yanagiuchi
- Recruiting
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, 880-2102
Kenji Ogata
- Recruiting
Osaka Keisatsu Hospital
Osaka, 543-8922
Osamu Iida
- Recruiting
Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
Sapporo, Hokkaido, 007-0849
Takuya Haraguchi
Germany3 sites, 3 recruiting
- Recruiting
Fürst Stirum Klinik Bruchsal Hospital
Bruchsal
Martin Andrassy
- Recruiting
University Clinic Essen-Hospital
Essen
Christos Rammos
- Recruiting
Klinikum der Ludwig-Maximilians-Universitat
München
Konstantinos Stavroulakis
Australia2 sites, 2 recruiting
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Nishath Altaf
- Recruiting
Royal North Shore Hospital
St Leonards, 2065
Vikram Puttaswamy
Canada2 sites, 1 recruiting
- Recruiting
Peter Lougheed Centre-Hospital
Calgary, Alberta
Ani Mirakhur
- Active, not recruiting
CHUS - Hotel Dieu
Sherbrooke, Quebec, J1H5N4
France2 sites, 1 recruiting
- Active, not recruiting
Hospital Marie Lannelongue
Le Plessis-Robinson, 92350
- Recruiting
Hospital Paris Saint Joseph
Paris
Yann Goueffic
Taiwan2 sites, 2 recruiting
- Recruiting
China Medical University Hospital
Taichung, 40408
Chung-Ho Hsu
- Recruiting
National Taiwan University Hospital
Taipei
Jen-Kuang Lee
Thailand2 sites, 2 recruiting
- Recruiting
Siriraj Hospital Department of Surgery
Bangkok, 10700
Nattawut Puangpunngam
- Recruiting
Prince of Songkla University
Hat Yai, 90110
Sorracha Rookkapan
Austria1 site, 1 recruiting
- Recruiting
Medizinische Univ.-Kliniken Graz
Graz, 8036
Marianne Brodmann
Poland1 site, 1 recruiting
- Recruiting
Uniwersyteckim Szpitalem Klinicznym w Poznaniu
Poznan, 60-355
Zbigniew Krasinski
Spain1 site, 1 recruiting
- Recruiting
Corporacio Sanitaria Parc Taulí, Barcelona
Sabadell
Marta Santos
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.Device
Ranger™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; ELUVIA™ Drug-Eluting Vascular Stent System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device. | |
| 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. Receives: Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events
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.
Measured: 12 months
Lesion Patency
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start29 Mar 2021
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674969
- Sponsor's protocol ID
- S2444
- Acronym
- ELEGANCE
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 37742734
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)
- ClinicalTrials.gov ID
- NCT04674969
- Acronym / sponsor ID
- ELEGANCE / S2444
- Conditions
- Peripheral Vascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Cohort | – | Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.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. |
| Outcomes Cohort | – | Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Life expectancy of <1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Clinical Cohort, Outcomes Cohort |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 37742734Secemsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
86 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Diseases, run by Boston Scientific Corporation at 86 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, China, Japan, Germany, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yumna Akhtar, MS (651-399-6775, yumna.akhtar@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04674969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.