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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04674969




Registration number
NCT04674969
Ethics application status
Date submitted
1/12/2020
Date registered
19/12/2020
Date last updated
16/05/2024

Titles & IDs
Public title
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
Scientific title
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)
Secondary ID [1] 0 0
S2444
Universal Trial Number (UTN)
Trial acronym
ELEGANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Vascular Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.

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.


Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Events
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Lesion Patency
Timepoint [2] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Life expectancy of <1 year

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2028
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Rhode Island
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
South Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Austria
State/province [25] 0 0
Graz
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
China
State/province [28] 0 0
Beijing
Country [29] 0 0
China
State/province [29] 0 0
Chongqing
Country [30] 0 0
China
State/province [30] 0 0
Guangdong
Country [31] 0 0
China
State/province [31] 0 0
Shandong
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Shanxi
Country [34] 0 0
China
State/province [34] 0 0
Xuhui District
Country [35] 0 0
France
State/province [35] 0 0
Le Plessis-Robinson
Country [36] 0 0
France
State/province [36] 0 0
Paris
Country [37] 0 0
Germany
State/province [37] 0 0
Bruchsal
Country [38] 0 0
Germany
State/province [38] 0 0
Essen
Country [39] 0 0
Germany
State/province [39] 0 0
München
Country [40] 0 0
Poland
State/province [40] 0 0
Poznan
Country [41] 0 0
Spain
State/province [41] 0 0
Sabadell
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei City
Country [44] 0 0
Thailand
State/province [44] 0 0
Bangkok
Country [45] 0 0
Thailand
State/province [45] 0 0
Hat Yai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04674969
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yumna Akhtar, MS
Address 0 0
Country 0 0
Phone 0 0
651-399-6775
Fax 0 0
Email 0 0
yumna.akhtar@bsci.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04674969