Status:
UNKNOWN
Clinical Trial of the WC360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures
Lead Sponsor:
Wound Care 360, Inc.
Conditions:
Bleeding
Eligibility:
All Genders
19-90 years
Phase:
NA
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.
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03234894
Start Date
April 1 2016
End Date
September 1 2020
Last Update
January 30 2020
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