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

Taewoong Medical

Status and phase

Terminated

Phase 3

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

Treatments

Device: Vascular Closure Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01597570

FASTSEAL® VCD

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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