The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter RemovalPhase 3NCT01597570
Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable VCD and Perclose® ProGlide SMC System
A Phase 3 study testing Vascular Closure Device in people with The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal, run by Taewoong Medical Co., Ltd. at 2 sites in South Korea.
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®… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal
- What is being tested?
- Vascular Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesSouth Korea
- Study dates
- May 2012to 10 Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Seoul, Irwon-Dong, Gangnam-Gu, 130-710
Severance Hospital
Seoul, Seodaemun Gu, 120-752
About this study
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
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.
Read the 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.
- Being tested
- Vascular Closure Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Closure DeviceDevice
Also called FASTSEAL® Bioabsorbable Vascular Access Closure System /, Perclose® ProGlide Suture-Mediated Closure System
To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
| Study group | Role | What they receive |
|---|---|---|
| FASTSEAL® Bioabsorbable VCD | Experimental | Fastseal® Bioabsorbable Vascular Access Closure System Receives: Device: Vascular Closure Device |
| Perclose® ProGlide SMC System | Active comparator | Perclose® ProGlide Suture-Mediated Closure System Receives: Device: Vascular Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTH; Time to hemostasis
Time interval between procedure and hemostasis
Measured: From the procedure start - 1m 30s, 2m 30s, 3m 30s, 4m 30s, 6m 30s, 8m 30s, 10m 30s
Secondary outcomes (1)
TTA(Time to ambulation) & Failure rate of hemostasis
Time interval between procedure and ambulation
Measured: From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startMay 2012
- Primary completion10 Dec 2012
- Study completion10 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taewoong Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongik Kim, Professor Dr., Principal investigator, Severance Hospital / Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597570
- Sponsor's protocol ID
- FASTSEAL® VCD
- Status last verified
- Jul 2017
- First submitted
- 10 May 2012
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01597570
- Acronym / sponsor ID
- FASTSEAL® VCD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Taewoong Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- 10 Dec 2012 (actual)
- Study completion
- 10 Dec 2012 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FASTSEAL® Bioabsorbable VCD | Experimental | Device: Vascular Closure DeviceFastseal® Bioabsorbable Vascular Access Closure System |
| Perclose® ProGlide SMC System | Active comparator | Device: Vascular Closure DevicePerclose® ProGlide Suture-Mediated Closure System |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular Closure DeviceAlso: FASTSEAL® Bioabsorbable Vascular Access Closure System /, Perclose® ProGlide Suture-Mediated Closure SystemTo reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site | Device | FASTSEAL® Bioabsorbable VCD, Perclose® ProGlide SMC System |
Primary outcome
TTH; Time to hemostasis
Time frame: From the procedure start - 1m 30s, 2m 30s, 3m 30s, 4m 30s, 6m 30s, 8m 30s, 10m 30s
Time interval between procedure and hemostasis
1 secondary outcome
TTA(Time to ambulation) & Failure rate of hemostasis
Time frame: From the procedure start - 2hr, 4hr, 6hr, 8hr, 12hr
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongik Kim, Professor Dr. principal investigator
Severance Hospital / Radiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vascular Closure Device in people with The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal, run by Taewoong Medical Co., Ltd. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TTH; Time to hemostasis (time frame: From the procedure start - 1m 30s, 2m 30s, 3m 30s, 4m 30s, 6m 30s, 8m 30s, 10m 30s). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.