Health Trials

About this 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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Evero DCB
  • Paclitaxel DCB

Treatment groups

410 Participants
are divided into 2 treatment groups

Locations

5
The Cardiac and Vascular Institute32605, GainesvilleFlorida, United States
First Coast Cardiovascular Institute32256, JacksonvilleFlorida, United States
Baptist Cardiac and Vascular Institute33176, MiamiFlorida, United States
North Mississippi Medical Center33801, TupeloMississippi, United States

Sponsors and collaborators

Cook Research Incorporated

Lead sponsor

Source ClinicalTrials.gov