EVERO Drug-coated Balloon (DCB) Randomized Trial

Cook Research Incorporated410 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

410

Conditions

Peripheral Vascular Disease Peripheral Arterial Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: 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.

Time frame: 12 months