Sealing the Arteriotomy
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the CloSys Hemostatic Device designed to stop bleeding after an interventional procedure.
Detailed description
To analyze the time to hemostasis (time to stop bleeding), time to ambulation (time to walk) and adverse events.
Interventions
DEVICECloSys Hemostatic Device (HD)
Deploy CloSys HD to achieve hemostasis
PROCEDUREStandard compression
Use standard compression to achieve hemostasis
Sponsors
Eminence Clinical Research, Inc.
CloSys Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria All answers must be YES to be eligible for the study: 1. Subject is ≥ 18 years of age; 2. Subject is willing and able to provide informed consent; 3. Subject is able to ambulate pre-procedure without difficulty; 4. Subject is able to remain supine for an extended period of time; 5. Subject is willing and able to comply with the requirements of the study protocol, including all follow-up visit evaluations; General
Exclusion criteria
All answers must be NO to be eligible for the study: 1. Subject has a systolic blood pressure (SBP) ≥ 160 mmHg despite medical therapy; 2. Subject has a diastolic blood pressure (DBP) ≥ 100 mmHg despite medical therapy; 3. Subject has received thrombolytic therapy, such as streptokinase, urokinase, retavase, tenecteplase, or tPA, within 24 hours of the scheduled procedure; 4. Subject is lactating; 5. Subject has a life expectancy of less than one (1) year; 6. The percutaneous intervention was an emergent procedure; 7. Subject has a known coagulopathy disorder, including, but not limited to, hemophilia, sickle cell disease, or von Willebrand disease; 8. Subject has a known diagnosis of an auto-immune disease; 9. Subject has a known or suspected diagnosis of vasculitis; 10. Subject currently has an infection of any kind; 11. Subject does not have either a posterior Tibialis (PT) or dorsalis pedis (DP) pulse by doppler in ipsilateral extremity; 12. Subject has critical limb ischemia and/or severe peripheral vascular disease as identified by rest pain and/or gangrene; 13. Rutherford category five (5) or six (6); 14. Subject is currently or within the last thirty (30) days participating in another investigational drug or device study; 15. Subject is unavailable for follow-up; 16. Subject has known allergy or previous intolerance to Protamine Sulfate; 17. Subject has known allergy to shellfish; 18. Subject has had a previous closure device in the ipsilateral side within the last ninety (90) days; 19. Prior intervention or surgical procedure to the access site within the last six (6) months; 20. Subject has a planned intervention or surgical procedure prior to completion of the thirty (30) day follow-up visit; 21. Subject has received a low molecular weight (LMWH) heparin, such as, Enoxaparin sodium (Lovenox, Xaparin and Clexane) within the past twelve (12) hours; 22. Body mass index (BMI) \> 45 or \< 20; 23. The investigator determines the subject is otherwise not an appropriate subject for the study; 5.3.2.1 Laboratory Values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to hemostasis | 1 Hour |
| Time to ambulation | 6 Hours |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | Within 30 days after procedure |
Countries
United States
Outcome results
None listed