The occurrence of Peripheral Vascular Disease has been increasing which includes the large artery in the upper leg called Superficial Femoral Artery (SFA). The Peritoneal Lined Stent has been developed as a new method for treating narrowed area in the SFA. This research study will determine the safety and effectiveness of the Peritoneal Lined Stent in keeping th Superficial Femoral Artery open and allowing blood to flow in the leg.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Peritoneal Lined Stent Endovascular Intervention
Pontificia Universidad Catolica de Chile
Santiago, Chile
RECRUITINGEfficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events
Time frame: 30 Days
Primary Patency Primary Assisted Patency Secondary Patency Clinical Success Major Amputations Target Vessel Revascularization Target Lesion Revascularization
Time frame: 3 Months Intervals except for Target Lesion Revascularization at 12 months
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