Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable VCD and Perclose® ProGlide SMC System
NCT ID: NCT01597570
Last Updated: 2017-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
52 participants
INTERVENTIONAL
2012-05-31
2012-12-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FASTSEAL® Bioabsorbable VCD
Fastseal® Bioabsorbable Vascular Access Closure System
Vascular Closure Device
To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
Perclose® ProGlide SMC System
Perclose® ProGlide Suture-Mediated Closure System
Vascular Closure Device
To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
Interventions
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Vascular Closure Device
To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
85 Years
ALL
No
Sponsors
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Taewoong Medical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dongik Kim, Professor Dr.
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital / Radiology
Locations
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Samsung Medical Center
Seoul, Irwon-Dong, Gangnam-Gu, South Korea
Severance Hospital
Seoul, Seodaemun Gu, South Korea
Countries
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Other Identifiers
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FASTSEAL® VCD
Identifier Type: -
Identifier Source: org_study_id
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