DCB Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropoplite… (NCT07136883) | Clinical Trial Compass
CompletedNot Applicable
DCB Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropopliteal Arterial Disease
Spain83 participantsStarted 2020-09-25
Plain-language summary
The goal of this clinical trial is to learn if using a scoring balloon to prepare the femoropopliteal (FP) segment before drug-coated balloon treatment works better than using a regular balloon (called plain old balloon angioplasty, or POBA). This study includes only people with critical limb ischemia (CLI).
The main questions it aims to answer are:
1. Does using a scoring balloon reduce the need for a bailout stent during the procedure?
2. Does a scoring balloon help keep the artery open longer?
3. Is the cost of the scoring balloon procedure similar to the cost of the POBA procedure?
Participants will:
* Receive either a scoring balloon or POBA to prepare the femoropopliteal segment
* Then be treated with a drug-coated balloon in the same segment
* Be monitored during the procedure to see if a bailout stent is needed
* Have follow-up visits to see if the artery remains open
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or non-pregnant female subjects aged ≥18 years at the time of informed consent. Women of childbearing potential must have a negative pregnancy test within 7 days prior to the procedure and must agree to use a reliable method of contraception during their participation in the study. This requirement does not apply in cases of sterility, infertility, or menopause for at least 12 months.
* Rutherford category 4-5.
* Life expectancy \>1 year as assessed by the investigator, based on the patient's medical history.
* Atherosclerotic lesions in the femoropopliteal segment, including in-stent restenosis.
* The subject has been informed, understands the nature of the trial, and has signed the informed consent form to participate in the study. If the subject is capable of understanding and providing informed consent but is physically unable to sign the consent form, an impartial witness may sign on their behalf.
* The patient is willing to comply with all required follow-up visits.
* Presence of at least one patent infragenicular artery (with \<50% stenosis) at the end of the procedure.
* Target vessel diameter ≤8 mm.
Exclusion Criteria:
* Pregnant women or women planning to become pregnant during the course of the study.
* Participation in another investigational drug eluting technology study.
* Inability to successfully cross the target lesion with a guidewire (successful crossing is defined as the guidewire tip passing through the lesion without perfora…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.