EVERO Drug-coated Balloon (DCB) Randomized Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Evero DCB: PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries

Paclitaxel DCB: PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries

Study 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

Primary outcome measure(s)

• Primary safety endpoint — 30 days (death); 12 months (amputation and CD-TLR)
  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)
• Primary effectiveness endpoint — 12 months
  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.

Trial sites (12)

More Cook Research Incorporated trials in the USA

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