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New treatment option for Peripheral Vascular Disease
Official title EVERO Drug-coated Balloon (DCB) Randomized Trial
ClinicalTrials.gov ID: NCT07144150
What this study is testing
What is Evero DCB?
Evero DCB is an investigational medicine, being studied as a potential treatment for peripheral vascular disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- General Exclusion Criteria
- 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...
- Unable or unwilling to comply with the follow-up schedule; or
See the full eligibility criteria
- 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.
- General Exclusion Criteria
- 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...
- Unable or unwilling to comply with the follow-up schedule; or
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tupelo, Mississippi, United States
- Greenville, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Tupelo, Mississippi, United States; Greenville, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.