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

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

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.

Study Overview

• Status: 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
• Intervention / Treatment: Device: Vascular Closure Device

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Irwon-Dong, Gangnam-Gu
    • Seoul, Irwon-Dong, Gangnam-Gu, Korea, Republic of, 130-710
      • Samsung Medical Center
  • Seodaemun Gu
    • Seoul, Seodaemun Gu, Korea, Republic of, 120-752
      • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taewoong Medical Co., Ltd.
• Investigators: Principal Investigator: Dongik Kim, Professor Dr., Severance Hospital / Radiology

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 10, 2012
• Study Completion (Actual): December 10, 2012

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (Estimate): May 14, 2012

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 23, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: FASTSEAL® VCD