Peripheral Vascular Disease study: Evero DCB vs Paclitaxel DCB
Official title EVERO Drug-coated Balloon (DCB) Randomized Trial
ClinicalTrials.gov ID: NCT07144150
What this study is testing
What is Evero DCB?
This is an investigational balloon catheter being studied to treat blockages in the leg arteries. It is designed to deliver a medicine called everolimus to the artery wall to help prevent the vessel from narrowing again.
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
- This study is testing whether a new balloon works as well as an older one. It also checks if it is just as safe.
- Who it's for
- You may be able to join if you have blockages in your leg arteries.
- What's involved
- You would get a balloon with medicine to open your artery. You might get the new balloon or an older one by chance.
- Time commitment
- The study follows you for a long time to check your health.
- 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 is enrolling
- Long Beach, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Davenport, Iowa, United States
- Bay City, Michigan, United States
- Tupelo, Mississippi, United States
- Lebanon, New Hampshire, United States
- Camden, New Jersey, United States
- Greenville, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Humble, Texas, 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, but 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?
This study is enrolling now at Long Beach, California, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Gainesville, Florida, United States; Jacksonville, Florida, United States; Miami, Florida, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.