Evaluation of the CloSys Closure System as an Adjunct to Standard Compression

Study Overview
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Brief Summary
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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
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To analyze the time to hemostasis (time to stop bleeding), time to ambulation (time to walk) and adverse events.

Official Title
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CloSys Hemostatic Device U.S. Multi-Center Clinical Investigation

Conditions
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Sealing the Arteriotomy

Intervention / Treatment
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* Device: CloSys Hemostatic Device (HD)
* Procedure: Standard compression


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria All answers must be YES to be eligible for the study: Subject is ≥ 18 years of age; Subject is willing and able to provide informed consent; Subject is able to ambulate pre-procedure without difficulty; Subject is able to remain supine for an extended period of time; 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: Subject has a systolic blood pressure (SBP) ≥ 160 mmHg despite medical therapy; Subject has a diastolic blood pressure (DBP) ≥ 100 mmHg despite medical therapy; Subject has received thrombolytic therapy, such as streptokinase, urokinase, retavase, tenecteplase, or tPA, within 24 hours of the scheduled procedure; Subject is lactating; Subject has a life expectancy of less than one (1) year; The percutaneous intervention was an emergent procedure; Subject has a known coagulopathy disorder, including, but not limited to, hemophilia, sickle cell disease, or von Willebrand disease; Subject has a known diagnosis of an auto-immune disease; Subject has a known or suspected diagnosis of vasculitis; Subject currently has an infection of any kind; Subject does not have either a posterior Tibialis (PT) or dorsalis pedis (DP) pulse by doppler in ipsilateral extremity; Subject has critical limb ischemia and/or severe peripheral vascular disease as identified by rest pain and/or gangrene; Rutherford category five (5) or six (6); Subject is currently or within the last thirty (30) days participating in another investigational drug or device study; Subject is unavailable for follow-up; Subject has known allergy or previous intolerance to Protamine Sulfate; Subject has known allergy to shellfish; Subject has had a previous closure device in the ipsilateral side within the last ninety (90) days; Prior intervention or surgical procedure to the access site within the last six (6) months; Subject has a planned intervention or surgical procedure prior to completion of the thirty (30) day follow-up visit; Subject has received a low molecular weight (LMWH) heparin, such as, Enoxaparin sodium (Lovenox, Xaparin and Clexane) within the past twelve (12) hours; Body mass index (BMI) > 45 or < 20; The investigator determines the subject is otherwise not an appropriate subject for the study; 5.3.2.1 Laboratory Values Exclusion Criteria All answers must be NO to be eligible for the study: Within seven (7) days prior to interventional procedure or according to standard of care for percutaneous interventional procedures requiring contrast and angiography: Subject is known to be, or suspected to be, pregnant (verified with a urine/blood pregnancy test); Subject's pre-procedural platelet count < 100,000 103/ul; Subject's hematocrit < 28%; Subject's hemoglobin < 10 g/dL; Subject's serum creatinine ≥ 2.5 mg/dL; Prothrombin Time (PT) is not within normal limits; Partial Thromboplastin Time (PTT) is not within normal limits; For subjects taking warfarin (Coumadin): The subject on warfarin within 30 days has an INR ≥ 1.8 at the time of procedure; post - Interventional Procedure Inclusion Criteria All answers must be YES to be eligible for the study: Subject has undergone a percutaneous interventional procedure utilizing a femoral arterial access; Heparin is administered for anti-coagulation during the procedure; Subject has an ACT ≥ 225 seconds and < 350 seconds; Subject's arterial introducer sheath is 5 Fr, 6 Fr or 7 Fr; Subject's arterial introducer sheath has an overall length of ≤ 15.0 cm; Subject's SBP < 160 mmHg; Subject's DBP < 100mmHg; Subject's physical, mental, and clinical status is stable and allows for ambulation assessment four (4) hours following removal of introducer sheath; 5.3.4 Post - Interventional Procedure Exclusion Criteria All answers must be NO to be eligible for the study: 5.3.4.1 General Exclusion Criteria Subject experienced cardiogenic shock before, during, or immediately after the interventional procedure; Subject has bleeding around the sheath prior to sheath removal; Subject has a pseudoaneurysm before sheath removal; Subject has a palpable hematoma before sheath removal; Subject has evidence of a retroperitoneal bleed prior to sheath removal; Subject experienced double wall punctures during vascular access; Subject experienced multiple arterial punctures (> 1) during vascular access; Subject has ipsilateral venous sheaths; Subject had intraprocedural therapeutic thrombolysis; Subject received bivalirudin(Angiomax®) before, during, or after the intervention; Subject received Protamine Sulfate IV to reverse heparin received during procedure; Subject has a suspected bacterial contamination of the access site; Arterial access was obtained in or near a vascular graft; Subject's percutaneous intervention was for the treatment of an acute myocardial infarction (MI); Angiographic Eligibility Criteria Angiographic Inclusion Criteria All answers must be YES to be eligible for the trial: Arterial access was obtained above the femoral bifurcation; Arterial access was obtained below the inguinal ligament; Angiographic Exclusion Criteria All answers must be NO to be eligible for the trial: Common femoral artery > 50% narrowing due to calcification or plaque; Arteriovenous fistula present; Other complication noted on femoral angiogram.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CloSys HD with standard compression<br>CloSys Arm | Device: CloSys Hemostatic Device (HD)<br>* Deploy CloSys HD to achieve hemostasis<br>Procedure: Standard compression<br>* Use standard compression to achieve hemostasis<br>|
| Active Comparator: Standard compression alone<br>Manual compression arm | Procedure: Standard compression<br>* Use standard compression to achieve hemostasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis |  | 1 Hour | 
| Time to ambulation |  | 6 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Within 30 days after procedure |