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
Qualifiers
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
Treatments tested in this trial
- Evero DCB
- Paclitaxel DCB
Treatment groups
410 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov