NCT07144150

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Evero DCB	PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
COMBINATION_PRODUCT	Paclitaxel DCB	PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-09-01
• Completion: 2032-10-01
• First posted: 2025-08-27
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study