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EVERO Drug-coated Balloon (DCB) Randomized Trial

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 11 to 12
  2. Study sites: 10 to 11
  3. Study sites: 9 to 10
    • Eligibility criteria expanded, about 8 words
  4. Study sites: 8 to 9v11
  5. Study sites: 7 to 8v10
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 5 to 7v9
  2. Study sites: 4 to 5v8
  3. Study sites: 3 to 4v7
  4. Study sites: 1 to 3
    • Start date changed from estimate of May 2026 to Apr 17, 2026
    v6
  1. Recruitment opened
    • Start date: Feb 2026 to May 2026
    • Study sites: 0 to 1
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Lead sponsor: [Redacted] to Cook Research Incorporatedv3 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Sep 2028
    • Study completion date: Oct 2032
    • Start date: Feb 2026
    • Study title shortened, about 7 words
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07144150
Lead Sponsor Cook Research Incorporated
Conditions
(from sponsor)		 Peripheral Vascular Disease, Peripheral Arterial Disease
Related terms Intermittent Claudication, Peripheral Arterial Disease, Peripheral Vascular Diseases
Enrollment 410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov