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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yumna Akhtar, MS | Contact | 651-399-6775 | yumna.akhtar@bsci.com | |
| Kara Johnson | Contact | 763-334-2963 | kara.johnson2@bsci.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Bernard's Medical Center | Recruiting | Jonesboro | Arkansas | 72401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37742734 | Derived | 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. |
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| PIH Health Good Samaritan Hospital | Recruiting | Los Angeles | California | 90017 | United States |
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| Cedars - Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| Ronald Reagan UCLA Medical Center | Withdrawn | Los Angeles | California | 90095 | United States |
| Sutter Medical Center, Sacramento | Completed | Sacramento | California | 95816 | United States |
| Adventist Health St Helena Hospital | Recruiting | St. Helena | California | 94574 | United States |
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| Yale University School of Medicine | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Christiana Hospital | Recruiting | Newport | Delaware | 19718 | United States |
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| Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Palm Beach Heart & Vascular, LLC | Withdrawn | Boynton Beach | Florida | 33436 | United States |
| Tallahassee Memorial Hospital | Recruiting | Tallahassee | Florida | 32308 | United States |
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| Emory University Hospital | Recruiting | Atlanta | Georgia | 30303 | United States |
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| South Georgia Medical Center | Recruiting | Valdosta | Georgia | 31602 | United States |
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| Rush University | Recruiting | Chicago | Illinois | 60612 | United States |
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| St. John's Hospital/ Prairie Education and Research Cooperative | Recruiting | Springfield | Illinois | 62701 | United States |
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| St. Joseph Hospital/Dupont Hospital | Withdrawn | Fort Wayne | Indiana | 46774 | United States |
| Ascension St. Vincent's Hospital | Recruiting | Indianapolis | Indiana | 46260 | United States |
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| CIS Clinical Research Corporation | Completed | Houma | Louisiana | 70360 | United States |
| Ochsner Clinic Foundation | Recruiting | Kenner | Louisiana | 70121 | United States |
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| Cardiovascular Institute of the South | Withdrawn | Lafayette | Louisiana | 70506 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Mercy Hospital (Allina Health) | Active, not recruiting | Coon Rapids | Minnesota | 55432 | United States |
| North Mississippi Medical Center | Recruiting | Tupelo | Mississippi | 38804 | United States |
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| Deborah Heart & Lung Center | Active, not recruiting | Browns Mills | New Jersey | 08015 | United States |
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Newark Beth Israel Medical Center | Recruiting | Newark | New Jersey | 07112 | United States |
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| Buffalo General Hospital | Recruiting | Buffalo | New York | 55313 | United States |
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| North Shore University Hospital/Northwell Health | Active, not recruiting | Manhasset | New York | 11030 | United States |
| New York University Medical Center | Recruiting | New York | New York | 10016 | United States |
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| Columbia University | Recruiting | New York | New York | 10027 | United States |
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| Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Memorial Sloan Kettering Hospital | Recruiting | New York | New York | 10065 | United States |
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| Weill Cornell Medicine/New York-Presbyterian Hospital | Recruiting | New York | New York | 10065 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Rex UNC Health (NC Heart and Vascular Research, LLC) | Recruiting | Raleigh | North Carolina | 27607 | United States |
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| University Hospitals of Cleveland | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Premier Cardiovascular Institute | Completed | Dayton | Ohio | 45409 | United States |
| Ascension St. John Clinical Research Institute | Recruiting | Tulsa | Oklahoma | 74104 | United States |
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| Pinnacle Health Cardiovascular Institute | Completed | Harrisburg | Pennsylvania | 17043 | United States |
| Hospital University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| The Miriam Hospital | Recruiting | Providence | Rhode Island | 02906 | United States |
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| Medical University of South Carolina | Active, not recruiting | Charleston | South Carolina | 29425 | United States |
| Monument Health Rapid City Hospital, Inc. | Completed | Rapid City | South Dakota | 57701 | United States |
| Seton Medical Center | Recruiting | Austin | Texas | 78705 | United States |
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| The University of Texas, Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| Texas Tech University Health Sciences Center | Completed | Lubbock | Texas | 79430 | United States |
| HeartPlace P.A. | Recruiting | Plano | Texas | 75075 | United States |
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| Inova Fairfax Hospital | Recruiting | Fairfax | Virginia | 22042 | United States |
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| UW Medicine - Harborview Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
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| Royal Perth Hospital | Recruiting | Perth | Western Australia | 6000 | Australia |
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| Royal North Shore Hospital | Recruiting | St Leonards | 2065 | Australia |
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| Medizinische Univ.-Kliniken Graz | Recruiting | Graz | 8036 | Austria |
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| Peter Lougheed Centre-Hospital | Recruiting | Calgary | Alberta | Canada |
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| CHUS - Hotel Dieu | Active, not recruiting | Sherbrooke | Quebec | J1H5N4 | Canada |
| Beijing Anzhen Hospital of the Capital University of Medical Sciences | Active, not recruiting | Chaoyang | Beijing Municipality | China |
| China-Japan Friendship Hospital | Active, not recruiting | Chaoyang | Beijing Municipality | China |
| Xuanwu Hospital Capital Medical University | Active, not recruiting | Xicheng | Beijing Municipality | China |
| The First Affiliated Hospital of Chongqing Medical University | Active, not recruiting | Chongqing | Chongqing Municipality | China |
| Zhongshan University No.1 Hospital | Active, not recruiting | Guangzhou | Guangdong | China |
| Affiliated Hospital of Medical College Qingdao University | Active, not recruiting | Qingdao | Shandong | China |
| Shanghai Ninth People's Hospital - Shanghai Jiaotong University School of Medicine | Active, not recruiting | Huangpu | Shanghai Municipality | China |
| Shanghai Changhai Hospital | Active, not recruiting | Yangpu | Shanghai Municipality | China |
| Shanxi Bethune Hospital | Active, not recruiting | Taiyuan | Shanxi | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Active, not recruiting | Xi’an | Shanxi | China |
| Shanghai Zhongshan Hospital | Active, not recruiting | Shanghai | Xuhui District | China |
| Hospital Marie Lannelongue | Active, not recruiting | Le Plessis-Robinson | 92350 | France |
| Hospital Paris Saint Joseph | Recruiting | Paris | France |
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| Fürst Stirum Klinik Bruchsal Hospital | Recruiting | Bruchsal | Germany |
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| University Clinic Essen-Hospital | Recruiting | Essen | Germany |
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| Klinikum der Ludwig-Maximilians-Universitat | Recruiting | München | Germany |
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| Uniwersyteckim Szpitalem Klinicznym w Poznaniu | Recruiting | Poznan | 60-355 | Poland |
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| Corporacio Sanitaria Parc Taulí, Barcelona | Recruiting | Sabadell | Spain |
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| China Medical University Hospital | Recruiting | Taichung | 40408 | Taiwan |
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| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| Siriraj Hospital Department of Surgery | Recruiting | Bangkok | 10700 | Thailand |
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| Prince of Songkla University | Recruiting | Hat Yai | 90110 | Thailand |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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