Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable VCD and Perclose® ProGlide SMC System

Study Overview
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Brief Summary
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It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access Closure System through effectiveness and safety confirmation of hemostasis (TTH; Time to hemstasis) and ambulation (TTA; Time to ambulation) at the puncture site of common femoral artery (CFA) after the procedures of Fastseal® Biosorbable Vascular Access Closure System or Perclose® ProGlide Suture-Mediated Closure System during 1 month observation.

Detailed Description
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Prospective, Single blind, randomized Comparative study using the Fastseal® Bioabsorbable Vascular Access Closure System as an investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a comparator. After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two devices. The subjects should follow designated physician's instructions accurately during the clinical trial period.There are about 6 times evaluations Including screening.

Official Title
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Clinical Evaluation of Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable Vascular Access Closure System and Perclose® ProGlide Suture-Mediated Closure System; Randomized, Comparative Study

Conditions
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The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal

Intervention / Treatment
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* Device: Vascular Closure Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 20 years old and 85 years old, randomized Patient who submitted a written informed consent for the this trial The subjects should be scheduled to have an angiography or intervention through the common femoral artery (CFA). The subjects must be used a 6Fr sheath of the Terumo's RadiFocus Introducer II. Exclusion Criteria: In case of the subject has a functure site in both legs. The patient who had the closing device insertion or manual compression at the targeted femoral artery within 30 days Patients with severe bleeding disorders (Severe bleeding history, blood coagulation disorder, thrombocytopenia (under 100,000 of platelet count), hemophilia, anemia (Hgb<10g/dL, Hct<30%), Thrombasthenia, any related bleeding disorder Hypertension patient BP ≥180/110mmHg In case of thrombolysis(ex: streptokinase, urokinase, t-PA) within 24hr If there is any hematoma, arteriovenous fistula(AVF), false aneurysm existed at the access site of femoral artery Severe obesity BMI > 40kg/m2 In case of prior stent placement or artificial vessel insertion in the common femoral artery(CFA) Under 5mm of Common femoral artery (CFA) diameter

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FASTSEAL® Bioabsorbable VCD<br>Fastseal® Bioabsorbable Vascular Access Closure System | Device: Vascular Closure Device<br>* To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site<br>* Other names: Perclose® ProGlide Suture-Mediated Closure System;|
| Active Comparator: Perclose® ProGlide SMC System<br>Perclose® ProGlide Suture-Mediated Closure System | Device: Vascular Closure Device<br>* To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site<br>* Other names: Perclose® ProGlide Suture-Mediated Closure System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TTH; Time to hemostasis | Time interval between procedure and hemostasis | From the procedure start - 1m 30s, 2m 30s, 3m 30s, 4m 30s, 6m 30s, 8m 30s, 10m 30s | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TTA(Time to ambulation) & Failure rate of hemostasis | Time interval between procedure and ambulation | From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr |