Recruiting

Evero DCB vs. pDCBs

Sponsor:

Cook Research Incorporated

Code:

NCT07144150

Conditions

Peripheral Vascular Disease

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Evero DCB

Paclitaxel DCB

Study Details

Brief 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).

Conditions

Peripheral Vascular Disease

Peripheral Arterial Disease

Study ID

NCT07144150

Start date

Apr 17, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2032

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Documented PAD with Rutherford classification 2 - 4; and
2. 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

1. Less than 18 years old;
2. Inability or refusal to give informed consent by the patient or legally authorized representative;
3. Life expectancy ≤ 12 months, per investigator assessment;
4. 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;
5. Unable or unwilling to comply with the follow-up schedule; or
6. 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.

Study Design

Enrollment

410 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Noah Shields

765-463-7537noah.shields@cookmedical.com

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

The Cardiac and Vascular Institute

Recruiting

Gainesville, Florida, United States, 32605

First Coast Cardiovascular Institute

Recruiting

Jacksonville, Florida, United States, 32256

Baptist Cardiac and Vascular Institute

Recruiting

Miami, Florida, United States, 33176

Midwest Cardiovascular Research Foundation

Recruiting

Davenport, Iowa, United States, 52801

North Mississippi Medical Center

Recruiting

Tupelo, Mississippi, United States, 33801

Prisma Health Memorial

Recruiting

Greenville, South Carolina, United States, 26905

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Cook Research Incorporated

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Intermittent claudication
  • Paclitaxel
  • Everolimus
  • Rapamycin
  • Drug-coated balloon (DCB)
  • Percutaneous transluminal angioplasty (PTA)
  • Femoropopliteal artery
  • Superficial femoral artery (SFA)
  • Popliteal artery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cook Research Incorporated on 2026-08-12.