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EVERO Drug-coated Balloon (DCB) Randomized Trial

Cook Research Incorporated · NCT07144150

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
410
US sites recruiting
12
Study start
April 17, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Evero DCB; Paclitaxel DCB

Conditions: Peripheral Vascular Disease; Peripheral Arterial Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

General Exclusion Criteria

  • 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;
  • Unable or unwilling to comply with the follow-up schedule; or
  • 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.

Recruiting US locations

Study contacts (from the official record)

  • Noah Shields · 765-463-7537 · noah.shields@cookmedical.com
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EVERO Drug-coated Balloon (DCB) Randomized Trial (NCT07144150) | Bored Studies