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

Phase 3

Terminated

• 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

• Registration Number: NCT01597570
• Lead Sponsor: Taewoong Medical Co., Ltd.

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-14
• Primary Completion: 2012-12-10
• Study Completion: 2012-12-10
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-23
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TTH; Time to hemostasis	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 Outcome Measures

Name	Time	Method
TTA(Time to ambulation) & Failure rate of hemostasis	From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr	Time interval between procedure and ambulation

Trial Locations

Locations (2)

Samsung Medical Center; 🇰🇷 Seoul, Irwon-Dong, Gangnam-Gu, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Seodaemun Gu, Korea, Republic of