Clinical trial NCT01597570: Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable VCD and Perclose® ProGlide SMC System
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
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
Lead sponsor: Taewoong Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-05-14
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: TTH; Time to hemostasis
timeFrame: From the procedure start - 1m 30s, 2m 30s, 3m 30s, 4m 30s, 6m 30s, 8m 30s, 10m 30s
Secondary outcomes:
measure: TTA(Time to ambulation) & Failure rate of hemostasis
timeFrame: From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Irwon-Dong, Gangnam-Gu
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun Gu
Study officials:
affiliation: Severance Hospital / Radiology
name: Dongik Kim, Professor Dr.
role: PRINCIPAL_INVESTIGATOR
References: