Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)
Cook Research Incorporated
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 o…
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
Location
- The Cardiac and Vascular InstituteGainesville, Florida