EVERO Drug-coated Balloon (DCB) Randomized Trial

A vizsgálat adatai

Ki végzi

Cook Research Incorporated

Azonosító

NCT07144150

A regiszteradat frissítve

2026. november 4.

Eredeti leírás

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).A teljes eredeti leírásKevesebb

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).

Bevonási feltételek: 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.

Kizáró feltételek: 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.

ClinicalTrials.gov NCT07144150