An interventional study of Serranator and POBA in Peripheral Arterial Disease and Critical Limb Ischemia, sponsored by Cagent Vascular LLC. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-09.
Sponsored by Cagent Vascular LLC · Not applicable, Interventional, and Treatment
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.
Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 20 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Cagent Vascular LLC is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Angiographic Inclusion Criteria:
Exclusion Criteria:
Angiographic Exclusion Criteria:
Device: Serranator
Device: POBA
Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular
Plain balloon angioplasty device
Presence of post treatment recoil
Obtain preliminary data on post treatment recoil in infrapopliteal arteries utilizing angiographic and IVUS data following serration angioplasty and standard angioplasty.
Time frame: 15 minutes post procedure
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Cagent Vascular LLC