The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
renal artery stenting
Munroe Regional Medical Center
Ocala, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Lenox Hill Hospital
New York, New York, United States
Wake Med Raleigh Campus
Raleigh, North Carolina, United States
Primary Patency of the Treated Renal Artery
Based on ultrasound images assessed by core lab.
Time frame: 9 Months
Number of Participants With 30-day Major Adverse Events
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Time frame: 30 Days
Number of Participants With 9-month Major Adverse Events
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Time frame: 9 Months
Technical Success
Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
Time frame: Prior to Discharge
Acute Procedural Success
\< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.
Time frame: Prior to Discharge
30-day Clinical Success
\< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.
Time frame: 30 Days
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Fairfield Medical Center
Lancaster, Ohio, United States
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, United States
Swedish Medical Center
Seattle, Washington, United States