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.