EVERO Drug-coated Balloon (DCB) Randomized Trial

NCT07144150 | Recruiting FDA Device

• 1 other identifier: 24-04
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Peripheral Vascular Disease; Peripheral Arterial Disease

Keywords

Intermittent claudication; Paclitaxel; Everolimus; Rapamycin; Drug-coated balloon (DCB); Percutaneous transluminal angioplasty (PTA); Femoropopliteal artery; Superficial femoral artery (SFA); Popliteal artery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Evero DCB

EXPERIMENTAL

Treatment with Evero drug-coated balloon to apply local treatment with everolimus

Combination Product: Evero DCB

Paclitaxel-coated DCB

ACTIVE COMPARATOR

Treatment with commercially-available drug-coated balloons to apply local treatment with paclitaxel

Combination Product: Paclitaxel DCB

Interventions

Evero DCB COMBINATION_PRODUCT

PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries

Evero DCB

Paclitaxel DCB COMBINATION_PRODUCT

PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries

Paclitaxel-coated DCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented PAD with Rutherford classification 2 - 4; and
• 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.

You may not qualify if:

• Less than 18 years old;
• Inability or refusal to give informed consent by the patient or legally authorized representative;
• Life expectancy ≤ 12 months, per investigator assessment;
• 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;
• Unable or unwilling to comply with the follow-up schedule; or
• 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.

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (3)

The Cardiac and Vascular Institute

Gainesville, Florida, 32605, United States

RECRUITING

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

NOT YET RECRUITING

Prisma Health Memorial

Greenville, South Carolina, 26905, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Secemsky, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Central Study Contacts

Noah Shields

CONTACT

765-463-7537; noah.shields@cookmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: April 17, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: Qualified scientific researchers

Locations

US (3)