EVERO Drug-coated Balloon (DCB) Randomized Trial

April 2, 2026 updated by: Cook Research Incorporated

Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)

The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon [DCB]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

410

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • The Cardiac and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Documented PAD with Rutherford classification 2 - 4; and
  2. De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries.

Exclusion Criteria:

General Exclusion Criteria

  1. Less than 18 years old;
  2. Inability or refusal to give informed consent by the patient or legally authorized representative;
  3. Life expectancy ≤ 12 months, per investigator assessment;
  4. Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure;
  5. Unable or unwilling to comply with the follow-up schedule; or
  6. Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evero DCB
Treatment with Evero drug-coated balloon to apply local treatment with everolimus
Combination product: Evero DCB
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Active Comparator: Paclitaxel-coated DCB
Treatment with commercially-available drug-coated balloons to apply local treatment with paclitaxel
Combination product: Paclitaxel DCB
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary safety endpoint
Time Frame: 30 days (death); 12 months (amputation and CD-TLR)
The primary safety endpoint is a composite assessment of freedom from device- or procedure-related death, freedom from target limb major amputation, and freedom from clinically-driven target lesion revascularization (CD-TLR)
30 days (death); 12 months (amputation and CD-TLR)
Primary effectiveness endpoint
Time Frame: 12 months
The primary effectiveness endpoint is primary patency defined as peak systolic velocity ratio ≤2.4 assessed by duplex ultrasound at 12 months and freedom from CD-TLR.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Research Incorporated

Investigators

  • Study Chair: Eric Secemsky, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

October 1, 2032

Study Registration Dates

First Submitted

August 20, 2025

First Submitted That Met QC Criteria

August 20, 2025

First Posted (Actual)

August 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.

html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

IPD Sharing Time Frame

Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication.

IPD Sharing Access Criteria

Qualified scientific researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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