Effectiveness and Safety Confirmation Between FASTSEAL® B... | NCT01597570

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Dec 10, 2012Actual

Completion Date

Dec 10, 2012Actual

First Submitted Date

May 10, 2012

First Submission Date that Met QC Criteria

May 10, 2012

First Posted Date

May 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2017

Last Update Posted Date

Jul 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vascular Closure Device	Device	To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site	FASTSEAL® Bioabsorbable VCD

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dongik Kim, Professor Dr.	Severance Hospital / Radiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul	Irwon-Dong, Gangnam-Gu	130-710	South Korea
Severance Hospital

ID	Term
D053831	Surgical Fixation Devices
D013523	Surgical Equipment
D004864	Equipment and Supplies