This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
The study design is a single arm with 90 patients. The primary endpoints measure the risk for common femoral nerve damage and common femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle. The sample size is 90 patients. The project objective is to demonstrate the safety of the device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
to evaluate the safety of the SiteSeal™ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
The percent of patients with common femoral nerve damage or with bleeding from femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
Femoral damage is indicated if the patient has an audible response during suture placement. Arterial laceration is visible bleeding during suture placement.
Time frame: 24 hours
Patient-rated patient discomfort.
Patients are called back after 24 hours and asked to rate their discomfort on a 1-10 scale. The mean of all patients 1-10scale rating is reported as the discomfort of the arm.
Time frame: 24 hour interview
The percent of patients who had a major complication.
Major complications are defined in the protocol. Major complications are summed and the mean of the entire arm is reported as a percent of patients who had major complications.
Time frame: 30day interview
The percent of patients who had a minor complication.
Minor complications are defined in the protocol. Minor complications are summed and the mean of the entire arm is reported as the percent of patients who had minor complications.
Time frame: 30day interview
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