Bleeding
Conditions
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 the soft tissue above the femoral bundle. The sample size is 90 patients. The project objective is to demonstrate the safety of the device.
Interventions
DEVICESiteSeal Endovascular
to evaluate the safety of the SiteSeal™ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
Sponsors
Wound Care 360, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24 hours | Femoral damage is indicated if the patient has an audible response during suture placement. Arterial laceration is visible bleeding during suture placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-rated patient discomfort. | 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. |
| The percent of patients who had a major complication. | 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. |
| The percent of patients who had a minor complication. | 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. |
Outcome results
None listed