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

NCT01597570 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-07-25

No results posted yet for this study

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.

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

Interventions

DEVICE

Vascular Closure Device

To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site

Sponsors & Collaborators

  • Taewoong Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dongik Kim, Professor Dr. · Severance Hospital / Radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-12-10
Completion
2012-12-10

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597570 on ClinicalTrials.gov