NCT07144150 EVERO Drug-coated Balloon (DCB) Randomized Trial
| NCT ID | NCT07144150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cook Research Incorporated |
| Condition | Peripheral Vascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2026-04-17 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 410 participants in total. It began in 2026-04-17 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Eric Secemsky, MD
STUDY CHAIR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT07144150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Vascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07144150 currently recruiting?
Yes, NCT07144150 is actively recruiting participants. Contact the research team at noah.shields@cookmedical.com for enrollment information.
Where is the NCT07144150 trial being conducted?
This trial is being conducted at New Haven, United States, Gainesville, United States, Jacksonville, United States, Miami, United States and 5 additional locations.
Who is sponsoring the NCT07144150 clinical trial?
NCT07144150 is sponsored by Cook Research Incorporated. The principal investigator is Eric Secemsky, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 410 participants.