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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674969
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment
Peripheral Vascular Diseases Device: Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Clinical Cohort
All enrolled patients are included in the Clinical Cohort and will complete assessments per standard of care through 5-year follow-up.
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

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.
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




Primary Outcome Measures :
  1. Major Adverse Events [ Time Frame: 12 months ]
    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.

  2. Lesion Patency [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674969


Contacts
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Contact: Yumna Akhtar, MS 651-399-6775 yumna.akhtar@bsci.com
Contact: Tracy E Swanson 763-329-0167 tracy.swanson@bsci.com

Locations
Show Show 63 study locations
Sponsors and Collaborators
Boston Scientific Corporation
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04674969    
Other Study ID Numbers: S2444
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases