EVERO Drug-coated Balloon (DCB) Randomized Trial

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Cook Research Incorporated
Study ID
NCT07144150
Status
Recruiting
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Conditions

  • Peripheral Arterial Disease
  • Peripheral Vascular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evero DCB — COMBINATION_PRODUCT
    PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
  • Paclitaxel DCB — COMBINATION_PRODUCT
    PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries

Study Details

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).

Key Dates

Start date
Apr 17, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Oct 31, 2032

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evero DCB
    Treatment with Evero drug-coated balloon to apply local treatment with everolimus
  • Active Comparator: Paclitaxel-coated DCB
    Treatment with commercially-available drug-coated balloons to apply local treatment with paclitaxel

Primary Outcome Measure

Primary safety endpoint [ Time Frame: 30 days (death); 12 months (amputation and CD-TLR) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
The Cardiac and Vascular InstituteGainesvilleFlorida32605-
Baptist Cardiac and Vascular InstituteMiamiFlorida33176-
Prisma Health MemorialGreenvilleSouth Carolina26905-

Find similar trials in Gainesville, FL

By research site
The Cardiac and Vascular Institute· Gainesville, FLBaptist Cardiac and Vascular Institute· Miami, FLPrisma Health Memorial· Greenville, SC

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