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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Evero DCB 		Treatment with Evero drug-coated balloon to apply local treatment with everolimus
  • Combination Product: Evero DCB
    PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Active Comparator
Paclitaxel-coated DCB 		Treatment with commercially-available drug-coated balloons to apply local treatment with paclitaxel
  • Combination Product: Paclitaxel DCB
    PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries

Recruiting Locations

The Cardiac and Vascular Institute
Gainesville, Florida 32605

More Details

Status
Recruiting
Sponsor
Cook Research Incorporated

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.