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 range18 Years
SexALL
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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…