Serranator Recoil Study (NCT05161039) | Clinical Trial Compass
UnknownNot Applicable
Serranator Recoil Study
United States, Germany20 participantsStarted 2021-11-15
Plain-language summary
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female of \>18 years old.
✓. Women of childbearing potential must have a negative urine pregnancy test within 7 days of index procedure.
✓. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and comply, and has signed the consent form.
✓. Subject has Rutherford Clinical Category 3, 4, 5, or 6.
✓. Target lesion(s) has stenosis \>70% by visual assessment;
✓. De-novo, or non-stented re-stenotic lesions;
✓. Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;
✓. Target lesions involve infrapopliteal tibial arteries including pedal;
Exclusion criteria
✕. Evidence of aneurysm or acute thrombus in the target vessel.
✕. Subject has an allergy to contrast medium that cannot be pretreated.
✕. Subject is pregnant or breastfeeding.
✕. Acute Total Occlusions; evidence of acute thrombus formation by angiography.