LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries (NCT04175197) | Clinical Trial Compass
UnknownNot Applicable
LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
Italy, Mexico512 participantsStarted 2019-11
Plain-language summary
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon
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:
Age ≥ 18 years or minimum age as required by local regulations.
* Subject with documented diagnosis of lower extremities arterial disease (LEAD).
* Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
* Positive diagnostic indication for PTA with a DEB in accordance with the Instructions For Use (IFU) of the Legflow DEB.
* Adequate distal run-off to the ankle (at least one native calf vessel \[posterior tibial, anterior tibial, or peroneal arteries\] is patent, defined as ≤ 50% diameter stenosis) either pre-existing or successfully re- established prior to target lesion treatment.
* Adequate inflow (≤ 50% diameter stenosis) either pre-existing or successfully re-established prior to target lesion treatment.
* Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before enrollment.
* Signed and dated Patient Informed Consent (PIC) form.
* Ability and willingness to comply with the clinical investigation plan (CIP).
* Life expectancy, in the Investigator's opinion, of at least 12 months
Exclusion Criteria:
* High probability of non-adherence to CIP follow-up requirements.
* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the a…
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.