5000 Participants Needed

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

(ELEGANCE Trial)

Recruiting at 85 trial locations
RF
DB
YA
TE
KJ
Overseen ByKara Johnson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston Scientific Corporation
Must be taking: Drug-eluting devices
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with commercially available drug-eluting devices for lesions in the peripheral vasculature

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments such as Quality of Life questionnaires and six-minute walk test

2 years

Extended Follow-up

Participants in China will continue follow-up assessments for an additional 3 years

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Boston Scientific Corporation (BSC) drug-eluting device
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Outcomes CohortExperimental Treatment1 Intervention
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.
Group II: Clinical CohortExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

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