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

The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01597570
• Other study ID #: FASTSEAL® VCD
• Status: Terminated
• Phase: Phase 3
• First received: May 10, 2012
• Last updated: July 23, 2017
• Start date: May 2012
• Est. completion date: December 10, 2012

Study information

• Verified date: July 2017
• Source: Taewoong Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: December 10, 2012
• Est. primary completion date: December 10, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal

Intervention

Device:
• Vascular Closure Device
To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Irwon-Dong, Gangnam-Gu
Korea, Republic of	Severance Hospital	Seoul	Seodaemun Gu

Sponsors (1)

Lead Sponsor	Collaborator
Taewoong Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TTA(Time to ambulation) & Failure rate of hemostasis	Time interval between procedure and ambulation	From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr