Femoral Arteriotomy ClosureNCT02406612
X-Seal EU Post-Market Clinical Follow-Up Protocol
A study testing X-Seal 6F Vascular Closure Device in people with Femoral Arteriotomy Closure, run by Essential Medical, Inc. at 2 sites in Germany.
Trial summary
The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Arteriotomy Closure
- What is being tested?
- X-Seal 6F Vascular Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2015to Jun 2016
- Phase
- Interventional
- 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
Who may be able to join
- Candidate for non-emergent diagnostic or interventional cardiac catheterization via a femoral sheath ≤6F.
- Age ≥18 years.
- Understand and sign the study specific written informed consent form.
- In the investigator's opinion, the patient is suitable for the X-Seal vascular closure device, conventional hemostasis techniques and participation in an investigational trial.
- Eligible for sheath removal in the catheterization lab.
Who cannot join
- Patients who are known to be pregnant or lactating.
- Patients who are immunocompromised.
- Prior target artery closure with any vascular closure device or closure with manual compression win 30 days prior to this procedure.
- Patients with significant anemia (hemoglobin <10 g/DL, Hct<30).
- Patients who are morbidly obese or cachectic (BMI >40 or <20 kg/m2).
- Patients with Systolic Blood Pressure >180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
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- Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period.
- Patients with a baseline INR > 1.5 (e.g. coumadin therapy).
- Patients with a known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand's disease.
- Patients with small femoral arteries (<4 mm), femoral artery stenosis resulting in a vessel diameter <4 mm, or patients with severe peripheral vascular disease.
- Patients with puncture site believed to be in the profunda femoris, superficial femoral artery, or at the bifurcation of the arteries.
- Common femoral artery with fluoroscopically visible calcium.
- Femoral arteries that are suspected to have experienced a back wall puncture or that underwent >one (1) arterial puncture during the catheterization procedure.
- Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula.
- Patients in whom continued heparin or other anticoagulant/antiplatelet therapy is planned (with the exception of Glycoprotein IIb/IIIa receptor blockers) following completion of the catheterization procedure.
- Patients whose ACT is >300 seconds prior to removal of the guiding catheter.
- Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence or life threatening disease.
- Prior femoral vascular surgery or vascular graft in region of access site.
- Patient is unable to ambulate at baseline.
- Acute ST-elevation MI within 48 hours prior to procedure.
- Active systemic or cutaneous infection or inflammation
- Patients with unilateral or bilateral lower extremity amputation
- Patients with renal insufficiency (serum creatinine >2.5 mg/dl)
- Patients with marked tortuosity of the femoral or iliac artery
- Patients in whom bacterial contamination of the procedure sheath or surrounding tissues may have occurred as this may result in infection
- Patients in whom the puncture site is located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed. Perform a femoral angiogram to verify the location of the puncture site
- Patients with known allergies to beef products, collagen and/or collagen products, or polyglycolic or polylactic acid polymers
- Patients with known allergy to stainless steel or nickel. See MRI information in the IFU.
- Patients undergoing therapeutic thrombolysis
- Patients punctured through a vascular graft
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Lubeck Hospital
Lübeck
University of Rostock Hosptial
Rostock
About this study
Official title: X-Seal 6F Vascular Closure Device EU Post-Market Clinical Follow-Up Protocol
The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared with standard compression techniques using data from literature surveys.
- Conditions
- Femoral Arteriotomy Closure
- Being tested
- X-Seal 6F Vascular Closure Device
- Keywords
- Vascular Closure Device, Femoral Artery Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-Seal 6F Vascular Closure DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| X-Seal 6F Vascular Closure Device | Experimental | The X-Seal 6F Vascular Closure device will be used to achieve hemostasis in both diagnostic and interventional procedures using up to a 6F procedure sheath. Receives: Device: X-Seal 6F Vascular Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Complications
The rate of major complications within approximately 30 days following the procedure.
Measured: 30 days
Time-to-Hemostasis
Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding.
Measured: Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours.
Secondary outcomes (2)
Time-to-Ambulation
The time from end of the procedure until the patient ambulates for the first time.
Measured: Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients.
Adverse Events
The rate of adverse events within approximately 30 days following the procedure. All AEs counted, whether or not device-related.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionJun 2016
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 Femoral Arteriotomy ClosureStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essential Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406612
- Sponsor's protocol ID
- PSD-028
- Status last verified
- Jan 2018
- First submitted
- 24 Mar 2015
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- X-Seal 6F Vascular Closure Device EU Post-Market Clinical Follow-Up Protocol
- ClinicalTrials.gov ID
- NCT02406612
- Acronym / sponsor ID
- PSD-028
- Conditions
- Femoral Arteriotomy Closure
- Keywords
- Vascular Closure Device, Femoral Artery Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Essential Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared with standard compression techniques using data from literature surveys.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X-Seal 6F Vascular Closure Device | Experimental | Device: X-Seal 6F Vascular Closure DeviceThe X-Seal 6F Vascular Closure device will be used to achieve hemostasis in both diagnostic and interventional procedures using up to a 6F procedure sheath. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidate for non-emergent diagnostic or interventional cardiac catheterization via a femoral sheath ≤6F.
- Age ≥18 years.
- Understand and sign the study specific written informed consent form.
- In the investigator's opinion, the patient is suitable for the X-Seal vascular closure device, conventional hemostasis techniques and participation in an investigational trial.
- Eligible for sheath removal in the catheterization lab.
Key exclusion criteria (30 listed)
- Patients who are known to be pregnant or lactating.
- Patients who are immunocompromised.
- Prior target artery closure with any vascular closure device or closure with manual compression win 30 days prior to this procedure.
- Patients with significant anemia (hemoglobin <10 g/DL, Hct<30).
- Patients who are morbidly obese or cachectic (BMI >40 or <20 kg/m2).
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 |
|---|---|---|
| X-Seal 6F Vascular Closure Device | Device | X-Seal 6F Vascular Closure Device |
Primary outcome
Major Complications
Time frame: 30 days
The rate of major complications within approximately 30 days following the procedure.
Time-to-Hemostasis
Time frame: Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours.
Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding.
2 secondary outcomes
Time-to-Ambulation
Time frame: Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients.
Adverse Events
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Femoral Arteriotomy Closure
Not yet recruiting
Safety and Effectiveness Clinical Study of Novelrad Vascular Closure System (NVCS)
Vascular Closure Device, Femoral Arteriotomy Closure
Active, not recruiting
The Ladera Large Bore Closure Feasibility Study
Vascular Closure, Femoral Arteriotomy Closure
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-Seal 6F Vascular Closure Device in people with Femoral Arteriotomy Closure, run by Essential Medical, Inc. at 2 sites in Germany.
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 5 inclusion and 30 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 29 Oct 2018. 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 Germany. 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 29 Oct 2018). 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?
Major Complications (time frame: 30 days). 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 29 Oct 2018.