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

Clinical Evaluation of Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable Vascular Access Closure System and Perclose® ProGlide Suture-Mediated Closure System; Randomized, Comparative Study

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01597570

Enrollment

Registered

2012-05-14

Start date

2012-05-31

Completion date

2012-12-10

Last updated

2017-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DEVICEVascular Closure Device

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
TTH; Time to hemostasis	From the procedure start - 1m 30s, 2m 30s, 3m 30s, 4m 30s, 6m 30s, 8m 30s, 10m 30s	Time interval between procedure and hemostasis

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026