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

Conditions

• Peripheral Vascular Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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 Details

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.

Key Dates

Start date

Mar 29, 2021

Status verified

May 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

5,000 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Major Adverse Events [ Time Frame: 12 months ]

Central Contacts

• Yumna Akhtar, MS
  651-399-6775
  [email protected]
• Kara Johnson
  763-334-2963
  [email protected]

Locations (52)

Find similar trials in Jonesboro, AR

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