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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01597570
First received: May 10, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal
Device: Vascular Closure Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable Vascular Access Closure System and Perclose® ProGlide Suture-Mediated Closure System; Randomized, Comparative Study

Further study details as provided by Taewoong Medical Co., Ltd.:

Primary Outcome Measures:
  • TTH; Time to hemostasis [ Time Frame: From the procedure start - 1m 30s, 2m 30s, 3m 30s, 4m 30s, 6m 30s, 8m 30s, 10m 30s ] [ Designated as safety issue: Yes ]
    Time interval between procedure and hemostasis


Secondary Outcome Measures:
  • TTA(Time to ambulation) & Failure rate of hemostasis [ Time Frame: From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr ] [ Designated as safety issue: Yes ]
    Time interval between procedure and ambulation


Estimated Enrollment: 116
Study Start Date: May 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597570

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Irwon-Dong, Gangnam-Gu, Korea, Republic of, 130-710
Severance Hospital
Seoul, Seodaemun Gu, Korea, Republic of, 120-752
Sponsors and Collaborators
Taewoong Medical Co., Ltd.
Investigators
Principal Investigator: Dongik Kim, Professor Dr. Severance Hospital / Radiology
  More Information

No publications provided

Responsible Party: Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01597570     History of Changes
Other Study ID Numbers: FASTSEAL® VCD
Study First Received: May 10, 2012
Last Updated: November 20, 2012
Health Authority: Korea:Korea food and Drug Administration(KFDA)

ClinicalTrials.gov processed this record on April 17, 2014