EVERO Drug-coated Balloon (DCB) Randomized Trial

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: Peripheral Arterial Disease; Peripheral Vascular Disease
• Intervention / Treatment: Combination product: Evero DCB; Combination product: Paclitaxel DCB

• Study Type: Interventional
• Enrollment (Estimated): 410
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noah Shields; Phone Number: 321174 765-463-7537; Email: noah.shields@cookmedical.com

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale New Haven Hospital
  • Florida
    • Gainesville, Florida, United States, 32605
      • Recruiting
      • The Cardiac and Vascular Institute
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • First Coast Cardiovascular Institute
    • Miami, Florida, United States, 33176
      • Recruiting
      • Baptist Cardiac and Vascular Institute
  • Iowa
    • Davenport, Iowa, United States, 52801
      • Recruiting
      • Midwest Cardiovascular Research Foundation
  • Mississippi
    • Tupelo, Mississippi, United States, 33801
      • Recruiting
      • North Mississippi Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 26905
      • Recruiting
      • Prisma Health Memorial
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

• Sponsor: Cook Research Incorporated
• Investigators: Study Chair: Eric Secemsky, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 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): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Everolimus; Rapamycin; Paclitaxel; Intermittent claudication; Percutaneous transluminal angioplasty (PTA); Popliteal artery; Drug-coated balloon (DCB); Femoropopliteal artery; Superficial femoral artery (SFA)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• 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