Drug-Eluting Devices for Peripheral Vascular Disease

(ELEGANCE Trial)

Recruiting at 89 trial locations

Overseen By Kara Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must be taking: Drug-eluting devices

Disqualifiers: Life expectancy <1 year

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather real-world data on the effectiveness of Boston Scientific's drug-eluting devices for treating blockages in blood vessels outside the heart, known as peripheral vascular disease (PVD). The research will also examine how these devices affect patients' quality of life and healthcare costs. Individuals managing PVD and using these specific devices might be suitable for the trial. Participants will undergo regular check-ups and assessments, with some taking part in additional evaluations such as quality of life surveys and a walking test. As a Phase 4 trial, this research seeks to understand how the already FDA-approved treatment benefits more patients, offering participants a chance to contribute to broader healthcare improvements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this drug-eluting device is safe for treating peripheral vascular lesions?

Research has shown that Boston Scientific's drug-releasing devices, such as the ELUVIA Drug-Eluting Vascular Stent, are designed to safely treat blockages in blood vessels. Studies have found that these devices can reduce the risk of amputation and hospital readmission compared to non-medication-releasing devices.

The FDA has approved the device, indicating it has passed safety checks for specific uses. However, important warnings exist. For instance, the device should not be used if its packaging is damaged. It is intended for one-time use only and should not be reused or cleaned for reuse.

Overall, evidence suggests the device is generally well-tolerated, but like any medical treatment, risks and precautions must be considered. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Boston Scientific Corporation's drug-eluting device because it offers a unique approach to treating lesions in the peripheral vasculature. Unlike typical treatments that may rely on mechanical methods or systemic drug delivery, this device combines a physical stent with localized drug release. This targeted delivery method aims to prevent restenosis, or re-narrowing of the blood vessels, by directly applying medication where it's needed most. The device's ability to address both structural support and localized drug therapy sets it apart from existing options, potentially enhancing long-term outcomes for patients.

What evidence suggests that the Boston Scientific Corporation drug-eluting device is effective for Peripheral Vascular Disease?

Research has shown that Boston Scientific's drug-coated devices effectively treat blockages in blood vessels outside the heart. Studies indicate these devices keep blood vessels open for at least a year. Specifically, one study found that the Eluvia device kept vessels clear in 86.8% of cases after a year, compared to 77.5% with another device. Overall, drug-coated devices have improved health outcomes by reducing the chance of blood vessels narrowing again. Participants in this trial will join either the Clinical Cohort or the Outcomes Cohort, both assessing the effectiveness of these devices. ^{3 6 7 8 9}

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?

Group I: Outcomes Cohort Experimental Treatment 1 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 Cohort Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

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

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

Citations

1. bostonscientific.com bostonscientific.com/en-US/medical-specialties/vascular-surgery/drug-eluting-therapies.html

Drug-eluting therapies 1-Year Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144). 4. DRG data, CY 2020, 0.018" PTA Balloons.

2. bostonscientific.com bostonscientific.com/en-US/medical-specialties/interventional-cardiology/coronary-interventions/clinical-data/coronary-drug-eluting-therapies-data.html

Coronary Drug-Eluting Therapies Data Primary endpoint1 met! AGENT DCB showed statistically superior outcomes compared to balloon angioplasty for TLF at 1-year. (17.9% versus 28.6% P= 0.003). The ...

3. news.bostonscientific.com news.bostonscientific.com/data-safety-efficacy-drug-eluting-stent-platforms

Clinical Data Reinforce Safety and Efficacy of ... Three-year results and two-year pooled analysis presented at ACC demonstrate continued positive outcomes for both PROMUS and TAXUS Stents.

4. bostonscientific.com bostonscientific.com/en-US/medical-specialties/vascular-surgery/drug-eluting-therapies/ranger/compare-clinical-trial-results.html

COMPARE clinical trial results Boston Scientific's Ranger Drug-Coated Balloon demonstrated near 90% primary patency at one year in two randomized controlled trials. Learn more here.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ccd.70082

Real‐World Safety and Complications of the Boston ... Drug-eluting stents (DES) have significantly improved clinical outcomes, reducing the incidence of restenosis compared to bare-metal stents ...

6. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/stents/vascular-stents/eluvia-drug-eluting-vascular-stent-system/fp00000362/eluvia-drug-eluting-vascular-stent-system-indications-safety-warnings.html

ELUVIA ™ Drug-Eluting Vascular Stent System Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative. For single use only. Do not reuse, reprocess or ...

7. bostonscientific.com bostonscientific.com/en-US/products/stents--coronary/synergy-xd/synergy-xd-indications-safety-warnings.html

Indications, Safety and Warnings Potential interactions of the SYNERGY Stent with other drug-eluting or coated stents have not been evaluated and should be avoided whenever possible.

8. bostonscientific.com bostonscientific.com/en-US/products/stents--coronary/promus-elite-permanent-polymer-stent/indications-safety-and-warnings.html

Promus ELITE Permanent Polymer Drug-Eluting Stent Use of the Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System is contraindicated in patients with known hypersensitivity to: ... Coronary ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180011B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The warnings and precautions can be found in the ELUVIA Drug-Eluting Vascular Self-. Expanding Stent System labeling. Page 2. PMA P180011: FDA ...