An interventional study of SBCV and Saline in Peripheral Arterial Disease, sponsored by Symic Vascular. Status unknown at 8 sites in 2 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-02-09.
Sponsored by Symic Vascular · Not applicable, Interventional, and Treatment
The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 66 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →This is the only study on the registry with Symic Vascular as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SBCV is administered to the site immediately post balloon dilation.
Other: SBCV
Saline is used as a control and is delivered immediately post balloon dilation.
Other: Saline
SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
Saline is used as a control.
Incidence of treatment-emergent adverse events
The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment: * Index limb amputation (above or below the ankle) * Index limb re-intervention * Index-limb-related death
Time frame: through 24 weeks
Late Lumen Loss
LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab.
Time frame: 24 weeks
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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