Clinical Trial of the WC360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures (SiteSeal)

January 28, 2020 updated by: Wound Care 360, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Patients between the ages 19 to 90
  2. Patient or his/her legally authorized representative, has given written informed consent for participation prior to the procedure
  3. Procedure is an interventional procedure
  4. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements
  5. Patient is a candidate for elective, non-emergent cardiac or peripheral vascular catheterization from the femoral artery approach
  6. Patient is willing to have a pre/post procedure ultrasound.

Exclusion Criteria:

  1. Patients are <19 years old
  2. Patients are >90years old
  3. Patient has received GP IIb/IIIa inhibitors
  4. Patient or patient's representative is unable to provide written informed consent.
  5. Patient is unable or unwilling to adhere to data collection and follow-up requirements
  6. Procedure is emergency PCI
  7. Patient is on dialysis
  8. Patient has a known diagnosis of fibromyalgia
  9. Patients with acute coronary syndrome (i.e., unstable angina or myocardial infarction) ≤ 48 hours before this catheterization procedure.
  10. Patients with systolic blood pressure < 90 mm Hg at the end of the catheterization procedure
  11. Patients who are immunocompromised
  12. Patients with preexisting systemic infection or local infections at the access site
  13. Patients who are known or suspected to be pregnant, or are lactating
  14. Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site above the inguinal ligament
  15. Patients who have undergone prior vascular closure device use in the ipsilateral common femoral artery ≤ 30days before this catheterization procedure
  16. 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
  17. Patients requiring a repuncture at a site previously punctured within 48 hours of the catheterization procedure
  18. Patients who have undergone an antegrade puncture
  19. Patients with puncture sites believed to be in the profunda femoris artery, superficial femoral artery, or at the bifurcation of these arteries
  20. Patients with puncture tract angle >55°
  21. Patients who are suspected to have experienced a femoral artery back wall puncture or who underwent > 1femoral artery puncture during the catheterization procedure
  22. Patient with significant anemia (hemoglobin < 10 g/dL, Hct < 30%)
  23. Patients with a known bleeding disorder, including thrombocytopenia (platelet count < 100,000 cells/μL), thrombasthenia, hemophilia, or von Willebrand's disease
  24. 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
  25. Patients with a baseline INR >1.5 (e.g., on warfarin therapy)
  26. Patients whose ACT >300seconds at the end of the catheterization procedure
  27. Patients who have undergone administration of low molecular weight heparin (LMWH) within 8hours of this catheterization procedure
  28. 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
  29. 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
  30. Patients with an ipsilateral or bilateral lower extremity amputation(s)
  31. Patient known to require extended hospitalization (e.g., patient is undergoing cardiac surgery)
  32. Patients who have a planned endovascular procedure within the next 30days after the catheterization procedure
  33. Patients who are currently participating in another investigational study that has not concluded the follow-up period
  34. Patients who have already participated in the IDE study
  35. Patients who cannot adhere to or complete the study for any reason including but not limited to geographical residence or life-threatening disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: SiteSeal Endovascular

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.
Device: SiteSeal Endovascular
to evaluate the safety of the SiteSeal™ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
Other Names:
  • SiteSeal Cardiovascular

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-rated patient discomfort.
Time Frame: 24 hour interview
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.
24 hour interview
The percent of patients who had a major complication.
Time Frame: 30day interview
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.
30day interview
The percent of patients who had a minor complication.
Time Frame: 30day interview
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.
30day interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wound Care 360, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elias Kassab, MD, MOVI
  • Principal Investigator: Matthew Earnest, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G150106/A001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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