BleedingSiteSealNCT03234894
Clinical Trial of the WC360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures
A study testing SiteSeal Endovascular in people with Bleeding, run by Wound Care 360, Inc..
Trial summary
This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Bleeding
- What is being tested?
- SiteSeal Endovascular
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Sep 2020
- Phase
- Interventional
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages 19 to 90
- Patient or his/her legally authorized representative, has given written informed consent for participation prior to the procedure
- Procedure is an interventional procedure
- Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements
- Patient is a candidate for elective, non-emergent cardiac or peripheral vascular catheterization from the femoral artery approach
- Patient is willing to have a pre/post procedure ultrasound.
Who cannot join
- Patients are <19 years old
- Patients are >90years old
- Patient has received GP IIb/IIIa inhibitors
- Patient or patient's representative is unable to provide written informed consent.
- Patient is unable or unwilling to adhere to data collection and follow-up requirements
- Procedure is emergency PCI
Show all 35Show fewer
- Patient is on dialysis
- Patient has a known diagnosis of fibromyalgia
- Patients with acute coronary syndrome (i.e., unstable angina or myocardial infarction) ≤ 48 hours before this catheterization procedure.
- Patients with systolic blood pressure < 90 mm Hg at the end of the catheterization procedure
- Patients who are immunocompromised
- Patients with preexisting systemic infection or local infections at the access site
- Patients who are known or suspected to be pregnant, or are lactating
- Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site above the inguinal ligament
- Patients who have undergone prior vascular closure device use in the ipsilateral common femoral artery ≤ 30days before this catheterization procedure
- Patients who have undergone prior use of manual or mechanical compression for closure in the ipsilateral common femoral artery ≤30 days before the catheterization procedure
- Patients requiring a repuncture at a site previously punctured within 48 hours of the catheterization procedure
- Patients who have undergone an antegrade puncture
- Patients with puncture sites believed to be in the profunda femoris artery, superficial femoral artery, or at the bifurcation of these arteries
- Patients with puncture tract angle >55°
- Patients who are suspected to have experienced a femoral artery back wall puncture or who underwent > 1femoral artery puncture during the catheterization procedure
- Patient with significant anemia (hemoglobin < 10 g/dL, Hct < 30%)
- Patients with a known bleeding disorder, including thrombocytopenia (platelet count < 100,000 cells/μL), thrombasthenia, hemophilia, or von Willebrand's disease
- Patients with systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg at the end of this catheterization procedure, unless systolic and/or diastolic pressure was lowered by pharmacological agents prior to the end of the catheterization procedure
- Patients with a baseline INR >1.5 (e.g., on warfarin therapy)
- Patients whose ACT >300seconds at the end of the catheterization procedure
- Patients who have undergone administration of low molecular weight heparin (LMWH) within 8hours of this catheterization procedure
- Patients in whom continued heparin or other anticoagulant/antiplatelet therapy is planned for this patient (with the exception of glycoprotein IIb/IIIa inhibitor therapy) during the first few hours following the catheterization procedure
- Patients having a complication or complications at the femoral artery access site during the catheterization procedure including bleeding, hematoma, intraluminal thrombus, pseudoaneurysm, or arteriovenous fistula
- Patients with an ipsilateral or bilateral lower extremity amputation(s)
- Patient known to require extended hospitalization (e.g., patient is undergoing cardiac surgery)
- Patients who have a planned endovascular procedure within the next 30days after the catheterization procedure
- Patients who are currently participating in another investigational study that has not concluded the follow-up period
- Patients who have already participated in the IDE study
- Patients who cannot adhere to or complete the study for any reason including but not limited to geographical residence or life-threatening disease
About this study
Official title: Clinical Study of the WoundCare360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures
This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
Read the detailed description
The study design is a single arm with 90 patients. The primary endpoints measure the risk for common femoral nerve damage and common femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
The sample size is 90 patients. The project objective is to demonstrate the safety of the device.
- Conditions
- Bleeding
- Being tested
- SiteSeal Endovascular
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiteSeal EndovascularDevice
Also called SiteSeal Cardiovascular
to evaluate the safety of the SiteSeal™ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
| Study group | Role | What they receive |
|---|---|---|
| SiteSeal Endovascular | Other | After intervention (deployment and removal of the Site Seal endovascular adjunctive compression device), the physician determines whether or not there was laceration of the femoral nerve or laceration of the femoral artery per protocol. A series of possible minor and/or major complications are noted per protocol.
There is a secondary metric as to patient reported pain on a 1-10scale. Receives: Device: SiteSeal Endovascular |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of patients with common femoral nerve damage or with bleeding from femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
Femoral damage is indicated if the patient has an audible response during suture placement. Arterial laceration is visible bleeding during suture placement.
Measured: 24 hours
Secondary outcomes (3)
Patient-rated patient discomfort.
Patients are called back after 24 hours and asked to rate their discomfort on a 1-10 scale. The mean of all patients 1-10scale rating is reported as the discomfort of the arm.
Measured: 24 hour interview
The percent of patients who had a major complication.
Major complications are defined in the protocol. Major complications are summed and the mean of the entire arm is reported as a percent of patients who had major complications.
Measured: 30day interview
The percent of patients who had a minor complication.
Minor complications are defined in the protocol. Minor complications are summed and the mean of the entire arm is reported as the percent of patients who had minor complications.
Measured: 30day interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Apr 2016
- Primary completion10 Sep 2018
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wound Care 360, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elias Kassab, MD, Principal investigator, MOVIMatthew Earnest, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234894
- Sponsor's protocol ID
- G150106/A001
- Acronym
- SiteSeal
- Status last verified
- Jan 2020
- First submitted
- 28 Jun 2016
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the WoundCare360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures
- ClinicalTrials.gov ID
- NCT03234894
- Acronym / sponsor ID
- SiteSeal / G150106/A001
- Conditions
- Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wound Care 360, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 31 Jul 2017 (actual)
- 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.
This Clinical Study is a pivotal study to evaluate the safety of the SiteSeal™ Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
Detailed description
The study design is a single arm with 90 patients. The primary endpoints measure the risk for common femoral nerve damage and common femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
The sample size is 90 patients. The project objective is to demonstrate the safety of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SiteSeal Endovascular | Other | Device: SiteSeal EndovascularAfter intervention (deployment and removal of the Site Seal endovascular adjunctive compression device), the physician determines whether or not there was laceration of the femoral nerve or laceration of the femoral artery per protocol. A series of possible minor and/or major complications are noted per protocol. There is a secondary metric as to patient reported pain on a 1-10scale. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients between the ages 19 to 90
- Patient or his/her legally authorized representative, has given written informed consent for participation prior to the procedure
- Procedure is an interventional procedure
- Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements
- Patient is a candidate for elective, non-emergent cardiac or peripheral vascular catheterization from the femoral artery approach
Key exclusion criteria (35 listed)
- Patients are <19 years old
- Patients are >90years old
- Patient has received GP IIb/IIIa inhibitors
- Patient or patient's representative is unable to provide written informed consent.
- Patient is unable or unwilling to adhere to data collection and follow-up requirements
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 |
|---|---|---|
| SiteSeal EndovascularAlso: SiteSeal Cardiovascularto evaluate the safety of the SiteSeal™ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures. | Device | SiteSeal Endovascular |
Primary outcome
The percent of patients with common femoral nerve damage or with bleeding from femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle.
Time frame: 24 hours
Femoral damage is indicated if the patient has an audible response during suture placement. Arterial laceration is visible bleeding during suture placement.
3 secondary outcomes
Patient-rated patient discomfort.
Time frame: 24 hour interview
The percent of patients who had a major complication.
Time frame: 30day interview
The percent of patients who had a minor complication.
Time frame: 30day interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Elias Kassab, MD principal investigator
MOVI
Matthew Earnest, MD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing SiteSeal Endovascular in people with Bleeding, run by Wound Care 360, Inc..
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 6 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The percent of patients with common femoral nerve damage or with bleeding from femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle. (time frame: 24 hours). 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 30 Jan 2020.