Clinical Evaluation of Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable Vascular Access Closure System and Perclose® ProGlide Suture-Mediated Closure System; Randomized, Comparative Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal
- Sponsor
- Taewoong Medical Co., Ltd.
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- TTH; Time to hemostasis
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
TTH; Time to hemostasis
Time Frame: From the procedure start - 1m 30s, 2m 30s, 3m 30s, 4m 30s, 6m 30s, 8m 30s, 10m 30s
Time interval between procedure and hemostasis
Secondary Outcomes
- TTA(Time to ambulation) & Failure rate of hemostasis(From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr)