Vascular ClosureSEAL PMNCT01858636
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
An observational study of Vascular Closure, run by Abbott Medical Devices at 6 sites in 2 countries.
Trial summary
To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Closure
- What is being tested?
- Angio-Seal VIP 6 French (6F) and 8 French (8F) devices
- Type of treatment
- Medical device
- How many people
- 235 participants
- Where
- 6 sitesin 2 countries
- Study dates
- May 2013to Oct 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that will be included in the study will be indicated for the procedure according to the Instructions for Use. Physicians should carefully select patients based on the IFU including a consideration of all warnings and precautions.
Who may be able to join
- Patient requires closure of femoral artery puncture resulting from arterial access procedure.
- Patient is ≥18 years of age.
- Patient is willing to provide written informed consent prior to study device use.
- Patient is willing and able to adhere to data collection and follow-up requirements.
Who cannot join
- Patient is participating in another clinical trial which has the potential to impact hemostasis.
- Patient has an active groin infection or systemic infection.
- Patient has undergone a vascular access procedure within the past 90 days.
- Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
Kerckhoff-Klinik GmbH
Bad Nauheim
Institut für Diagnostiche und Interventionelle Radiologie
Frankfurt
Univ. des Saarlandes
Homburg
Herzzentrum Leipzig GMBH
Leipzig
Netherlands2 sites
Amphia Ziekenhuis
Breda
Medisch Spectrum Twente
Enschede
About this study
To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.
- Conditions
- Vascular Closure
- Being tested
- Angio-Seal VIP 6 French (6F) and 8 French (8F) devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angio-Seal VIP 6 French (6F) and 8 French (8F) devicesDevice
These devices are used for the vascular closure procedure
| Study group | Role | What they receive |
|---|---|---|
| Angio-Seal VIP Vascular Closure | Not described Receives: Device: Angio-Seal VIP 6 French (6F) and 8 French (8F) devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication
Major vascular complications include:
Access Site Complications:
- Hematoma >10 cm in size requiring surgical or percutaneous intervention
- Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention
- Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention
- Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics
- A/V Fistula requiring medical intervention (percutaneous or surgical)
- Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)
Measured: 30 days post procedure
The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.
Measured: within 5 minutes of device deployment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular ClosureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858636
- Sponsor's protocol ID
- CL06818
- Acronym
- SEAL PM
- Status last verified
- Feb 2019
- First submitted
- 14 May 2013
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
- ClinicalTrials.gov ID
- NCT01858636
- Acronym / sponsor ID
- SEAL PM / CL06818
- Conditions
- Vascular Closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Posted 18 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angio-Seal VIP Vascular Closure | – | Device: Angio-Seal VIP 6 French (6F) and 8 French (8F) devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that will be included in the study will be indicated for the procedure according to the Instructions for Use. Physicians should carefully select patients based on the IFU including a consideration of all warnings and precautions.
Key inclusion criteria (4 listed)
- Patient requires closure of femoral artery puncture resulting from arterial access procedure.
- Patient is ≥18 years of age.
- Patient is willing to provide written informed consent prior to study device use.
- Patient is willing and able to adhere to data collection and follow-up requirements.
Key exclusion criteria (4 listed)
- Patient is participating in another clinical trial which has the potential to impact hemostasis.
- Patient has an active groin infection or systemic infection.
- Patient has undergone a vascular access procedure within the past 90 days.
- Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)
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 |
|---|---|---|
| Angio-Seal VIP 6 French (6F) and 8 French (8F) devicesThese devices are used for the vascular closure procedure | Device | Angio-Seal VIP Vascular Closure |
Primary outcome
The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication
Time frame: 30 days post procedure
Major vascular complications include: Access Site Complications: * Hematoma >10 cm in size requiring surgical or percutaneous intervention * Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention * Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention * Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics * A/V Fistula requiring medical intervention (percutaneous or surgical) * Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)
The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.
Time frame: within 5 minutes of device deployment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Closure, run by Abbott Medical Devices at 6 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Netherlands. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication (time frame: 30 days post procedure). The study lists 2 primary outcomes in all. 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 5 Feb 2019.