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

NCT03234894 | Unknown DMC FDA Device

• 1 other identifier: G150106/A001
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (3)

• Patient-rated patient discomfort.

  24 hour interview

• The percent of patients who had a major complication.

  30day interview

• The percent of patients who had a minor complication.

  30day interview

Study Arms (1)

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.

Device: SiteSeal Endovascular

Interventions

SiteSeal Endovascular DEVICE

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

Also known as: SiteSeal Cardiovascular

SiteSeal Endovascular

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wound Care 360, Inc.: lead

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elias Kassab, MD

  MOVI

  PRINCIPAL INVESTIGATOR

• Matthew Earnest, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 31, 2017
• Study Start: April 1, 2016
• Primary Completion: September 10, 2018
• Study Completion: September 1, 2020
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share