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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014