Registry for real-world treatment of peripheral vascular lesions
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)
Boston Scientific Corporation · NCT04674969
This study is trying to see how well drug-eluting devices from Boston Scientific work for treating peripheral vascular diseases in a wide range of patients in real-world settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation (industry) |
| Locations | 79 sites (Jonesboro, Arkansas and 78 other locations) |
| Trial ID | NCT04674969 on ClinicalTrials.gov |
What this trial studies
The ELEGANCE Registry aims to gather Real-World Data (RWD) on the treatment of peripheral vascular diseases using commercially available drug-eluting devices from Boston Scientific Corporation. This global, prospective, non-randomized, open-label registry will include diverse patient populations that have been underrepresented in previous clinical trials. The data collected will encompass health economics and safety information to support the effective use of these devices in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients aged 18 years and older who require treatment for lesions in the peripheral vasculature using Boston Scientific drug-eluting devices.
Not a fit: Patients with a life expectancy of less than one year may not benefit from participation in this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding and treatment of peripheral vascular diseases, leading to improved patient outcomes.
How similar studies have performed: Other studies utilizing real-world data for similar conditions have shown promise, indicating that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Exclusion Criteria: * Life expectancy of \<1 year
Where this trial is running
Jonesboro, Arkansas and 78 other locations
- St. Bernard's Medical Center — Jonesboro, Arkansas, United States (RECRUITING)
- PIH Health Good Samaritan Hospital — Los Angeles, California, United States (RECRUITING)
- Cedars - Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States (WITHDRAWN)
- Sutter Medical Center, Sacramento — Sacramento, California, United States (COMPLETED)
- Adventist Health St Helena Hospital — St. Helena, California, United States (RECRUITING)
- Yale University School of Medicine — New Haven, Connecticut, United States (RECRUITING)
- Christiana Hospital — Newport, Delaware, United States (RECRUITING)
- Washington Hospital Center — Washington D.C., District of Columbia, United States (RECRUITING)
- Palm Beach Heart & Vascular, LLC — Boynton Beach, Florida, United States (WITHDRAWN)
- Tallahassee Memorial Hospital — Tallahassee, Florida, United States (RECRUITING)
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
- South Georgia Medical Center — Valdosta, Georgia, United States (RECRUITING)
- Rush University — Chicago, Illinois, United States (RECRUITING)
- St. John's Hospital/ Prairie Education and Research Cooperative — Springfield, Illinois, United States (ACTIVE_NOT_RECRUITING)
- St. Joseph Hospital/Dupont Hospital — Fort Wayne, Indiana, United States (WITHDRAWN)
- Ascension St. Vincent's Hospital — Indianapolis, Indiana, United States (RECRUITING)
- CIS Clinical Research Corporation — Houma, Louisiana, United States (COMPLETED)
- Ochsner Clinic Foundation — Kenner, Louisiana, United States (RECRUITING)
- Cardiovascular Institute of the South — Lafayette, Louisiana, United States (WITHDRAWN)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
- Mercy Hospital (Allina Health) — Coon Rapids, Minnesota, United States (ACTIVE_NOT_RECRUITING)
- North Mississippi Medical Center — Tupelo, Mississippi, United States (RECRUITING)
- Deborah Heart & Lung Center — Browns Mills, New Jersey, United States (ACTIVE_NOT_RECRUITING)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (RECRUITING)
- Newark Beth Israel Medical Center — Newark, New Jersey, United States (RECRUITING)
- Buffalo General Hospital — Buffalo, New York, United States (RECRUITING)
- North Shore University Hospital/Northwell Health — Manhasset, New York, United States (ACTIVE_NOT_RECRUITING)
- New York University Medical Center — New York, New York, United States (RECRUITING)
- Columbia University — New York, New York, United States (RECRUITING)
- Mount Sinai — New York, New York, United States (RECRUITING)
- Memorial Sloan Kettering Hospital — New York, New York, United States (RECRUITING)
- Weill Cornell Medicine/New York-Presbyterian Hospital — New York, New York, United States (RECRUITING)
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
- Rex UNC Health (NC Heart and Vascular Research, LLC) — Raleigh, North Carolina, United States (RECRUITING)
- University Hospitals of Cleveland — Cleveland, Ohio, United States (RECRUITING)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
- Premier Cardiovascular Institute — Dayton, Ohio, United States (COMPLETED)
- Ascension St. John Clinical Research Institute — Tulsa, Oklahoma, United States (RECRUITING)
- Pinnacle Health Cardiovascular Institute — Harrisburg, Pennsylvania, United States (COMPLETED)
- Hospital University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (RECRUITING)
- The Miriam Hospital — Providence, Rhode Island, United States (RECRUITING)
- Medical University of South Carolina — Charleston, South Carolina, United States (ACTIVE_NOT_RECRUITING)
- Monument Health Rapid City Hospital, Inc. — Rapid City, South Dakota, United States (COMPLETED)
- Seton Medical Center — Austin, Texas, United States (RECRUITING)
- The University of Texas, Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
- Baylor College of Medicine — Houston, Texas, United States (RECRUITING)
- Texas Tech University Health Sciences Center — Lubbock, Texas, United States (COMPLETED)
- HeartPlace P.A. — Plano, Texas, United States (RECRUITING)
+29 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Yumna Akhtar, MS
- Email: yumna.akhtar@bsci.com
- Phone: 651-399-6775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Vascular Diseases