EVERO Drug-coated Balloon (DCB) Randomized Trial
Key facts
- Where
- Bay City, Camden, Dallas, Davenport, Gainesville, Greenville, Houston, Humble, Jacksonville, Lebanon, Long Beach, Miami, New Haven, Tupelo, and Washington D.C., United StatesSee the 15 sites
Where in United States
- McLaren Bay Region HospitalBay City, United StatesContact: Noah ShieldsTaking people
- Cooper University HospitalCamden, United StatesContact: Noah ShieldsTaking people
- University of Texas, SouthwesternDallas, United StatesContact: Noah ShieldsTaking people
- Midwest Cardiovascular Research FoundationDavenport, United StatesContact: Noah ShieldsTaking people
- The Cardiac and Vascular InstituteGainesville, United StatesContact: Noah ShieldsTaking people
- Prisma Health MemorialGreenville, United StatesContact: Noah ShieldsTaking people
- Houston Methodist HospitalHouston, United StatesContact: Noah ShieldsTaking people
- Vital Heart and VeinHumble, United StatesContact: Noah ShieldsTaking people
- First Coast Cardiovascular InstituteJacksonville, United StatesContact: Noah ShieldsTaking people
- Dartmouth Hitchcock Medical CenterLebanon, United StatesContact: Noah ShieldsTaking people
- Long Beach Veterans Administration Hospital/SCIRE ResearchLong Beach, United StatesContact: Noah ShieldsTaking people
- Baptist Cardiac and Vascular InstituteMiami, United StatesContact: Noah ShieldsTaking people
- Yale New Haven HospitalNew Haven, United StatesContact: Noah ShieldsTaking people
- North Mississippi Medical CenterTupelo, United StatesContact: Noah ShieldsTaking people
- Medstar Georgetown University HopsitalWashington D.C., United StatesContact: Noah ShieldsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Cook Research Incorporated
- Trial code
- NCT07144150
- Record updated
- 4 November 2026
- Original description
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).Read full original descriptionShow less
Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO 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).
Inclusion: 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.
Exclusion: 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; Less than 18 years old; General Exclusion Criteria; 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.