RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)

Exclusion Criteria

• •1. Advanced refusal of blood transfusion, if necessary;
• •2. Active systemic or a cutaneous infection or inflammation;
• •3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
• •4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
• •5. Severe co-existing morbidities having a life expectancy of less than 30 days;
• •6. Currently involved in any other investigational clinical trial;
• •7. Ipsilateral femoral arteriotomy within the previous 30 days;
• •8. Planned endovascular procedure within the next 30 days;
• •9. Previous ipsilateral femoral artery closure using a permanent implant-based closure device;
• •10. Previous vascular grafts or surgery at the target vessel access site;
• •11. History of symptomatic peripheral arterial disease, revascularization or deep vein thrombosis in the ipsilateral limb;
• •12. Unilateral or bilateral lower extremity amputation(s);
• •13. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
• •14. Renal insufficiency (serum creatinine of \> 2.5 mg/dl);
• •15. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
• •16. Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
• •17. Unable to routinely walk at least 20 feet without assistance (see protocol);
• •18. Known allergy/adverse reaction to bovine derivatives, sodium hyaluronate or hyaluronan preparations;
• •19. Procedures that extend hospitalization (e.g., staged endovascular procedure, CABG);
• •20. Administration of low molecular weight heparin (LMWH) within 8 hours of the procedure.
• •1. An introducer sheath with an overall length greater than 11 cm, or not 6 Fr or 7 Fr diameter;
• •2. Femoral artery diameter less than 6 mm at access site;
• •3. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, "back wall stick", etc.);
• •4. Angiographic evidence of more than minimal calcium, atherosclerotic disease, or stent within 1 cm of the puncture site;
• •5. Overlapping Common Femoral Vein and Femoral Artery at access site;
• •6. Placement of ipsilateral venous sheath during procedure;
• •7. Arterial access site located not at common femoral artery (e.g., on or below the bifurcation, above the lower border of the inferior epigastric artery, or above the pelvic brim);
• •8. More than one access site required;
• •9. Loss of distal pulses in the ipsilateral extremity during the procedure;
• •10. Subjects receiving unfractionated heparin with an ACT greater than 300 seconds in the absence of a glycoprotein IIb/IIIa inhibitor or greater than 250 seconds in the presence of a glycoprotein IIb/IIIa inhibitor (may wait to remove introducer sheath until ACT level reaches the target value);
• •11. Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula;
• •12. Systemic hypertension (BP greater than 180/110 mmHg) or hypotension (BP less than 90/60 mmHg) prior to randomization;
• •13. Length of the tissue tract, the distance between the anterior arterial wall and skin, is estimated to be less than 2.5 cm;
• •14. If the physician deems that a different method should be used to achieve hemostasis of the arterial site or that the subject should not attempt ambulation according to the protocol requirements.