NCT01597570

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2012

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

May 10, 2012

Last Update Submit

July 23, 2017

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • TTA(Time to ambulation) & Failure rate of hemostasis

    From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr

Study Arms (2)

FASTSEAL® Bioabsorbable VCD

EXPERIMENTAL

Fastseal® Bioabsorbable Vascular Access Closure System

Device: Vascular Closure Device

Perclose® ProGlide SMC System

ACTIVE COMPARATOR

Perclose® ProGlide Suture-Mediated Closure System

Device: Vascular Closure Device

Interventions

Vascular Closure DeviceDEVICE

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

Also known as: FASTSEAL® Bioabsorbable Vascular Access Closure System /, Perclose® ProGlide Suture-Mediated Closure System
FASTSEAL® Bioabsorbable VCDPerclose® ProGlide SMC System

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, Irwon-Dong, Gangnam-Gu, 130-710, South Korea

Location

Severance Hospital

Seoul, Seodaemun Gu, 120-752, South Korea

Location

MeSH Terms

Interventions

Vascular Closure Devices

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Dongik Kim, Professor Dr.

    Severance Hospital / Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 14, 2012

Study Start

May 1, 2012

Primary Completion

December 10, 2012

Study Completion

December 10, 2012

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

KR(2)