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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07144150

Enrollment

410

Registered

2025-08-27

Start date

2026-05-01

Completion date

2032-10-01

Last updated

2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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).

Interventions

COMBINATION_PRODUCTEvero DCB

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

COMBINATION_PRODUCTPaclitaxel DCB

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary safety endpoint	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)
Primary effectiveness endpoint	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.

Countries

United States

Contacts

CONTACTNoah Shields

noah.shields@cookmedical.com765-463-7537

STUDY_CHAIREric Secemsky, MD

Beth Israel Deaconess Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026