SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study (NCT03266835) | Clinical Trial Compass
CompletedNot Applicable
SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study
United States, Canada15 participantsStarted 2017-11-16
Plain-language summary
This study is aimed at demonstrating the efficacy and safety of the SoundBite™ Crossing System-Peripheral. The study is intended to demonstrate that the SoundBite™ Crossing System can facilitate the passage of either devices intended to treat a chronic total occlusion (CTO) or additional crossing devices through an infrainguinal CTO into the true lumen.
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
âś“. Has symptomatic chronic limb ischemia, requiring treatment of an in:frainguinal artery
âś“. Has Rutherford Clinical Category of 2-5
✓. Is ≥ 18 years old
âś“. Has life expectancy \> 1 year
âś“. Is able and willing to provide written informed consent prior to study procedure
âś“. Has evidence of a clinically significant de novo CTO located in a peripheral vessel below the infrainguinal ligament confirmed by angiography at time of procedure.
âś“. Notwithstanding criteria 1, multilevel CTOs are included as long as the total length from the beginning of the most proximal total occlusion to the end of the most distal total occlusion is less than 40 cm.
âś“. 100% stenosis by visual estimate of angiography at time of procedure.
Exclusion criteria
âś•. Has had a previous peripheral bypass that includes the target vessel.
âś•. Has had a previous intervention on the target CTO (e.g., angioplasty, stent placement), including previous attempt at time of index procedure.
âś•. History of any vascular procedure on the index limb within the last 30 days requiring clinically driven re-intervention.
âś•. Has an active infection in the target limb.
What they're measuring
1
Technical Device Success
Timeframe: Day 1
2
Freedom from SoundBite™ Crossing System related MAEs at 30 days post procedure