EVERO Drug-coated Balloon (DCB) Randomized Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCook Research Incorporated
About this trial
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
This trial does not accept healthy volunteersQualifiers
Documented PAD with Rutherford classification 2 - 4; and
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.
Disqualifiers
Less than 18 years old;
Inability or refusal to give informed consent by the patient or legally authorized representative;
Life expectancy ≤ 12 months, per investigator assessment;
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Evero DCB
Combination productPTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Paclitaxel DCB
Combination productPTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Treatment groups
410 Participants
are divided into 2 treatment groupsGroup A: Evero DCBExperimental treatment 1 intervention
Group B: Paclitaxel-coated DCBActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary safety endpoint
The primary safety endpoint is a composite assessment of freedom from device- or procedure-related death, freedom from target limb major amputation, and freedom from clinically-driven target lesion revascularization (CD-TLR)
Time frame
30 days (death); 12 months (amputation and CD-TLR)2
Primary effectiveness endpoint
The primary effectiveness endpoint is primary patency defined as peak systolic velocity ratio ≤2.4 assessed by duplex ultrasound at 12 months and freedom from CD-TLR.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov