An observational study in Peripheral Vascular Diseases, sponsored by Boston Scientific Corporation. Recruiting at 86 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Boston Scientific Corporation · Observational
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.
443 studies on the registry are indexed under Peripheral Vascular Diseases; 44 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 217 across 86 observational studies indexed under Peripheral Vascular Diseases.
Browse Peripheral Vascular Diseases studies →Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Time frame: 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.
Time frame: 12 months
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Peripheral Vascular Diseases →
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