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

Pre-Operative Inclusion Criteria:

• Patients undergoing an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 6 or 7 Fr introducer sheath

Pre-Operative Exclusion Criteria:

• Advanced refusal of blood transfusion, if necessary;
• Active systemic or a cutaneous infection or inflammation;
• Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
• Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count 2.5 mg/dl);
• Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
• Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
• Unable to routinely walk at least 20 feet without assistance (see protocol);
• Known allergy/adverse reaction to bovine derivatives, sodium hyaluronate or hyaluronan preparations;
• Procedures that extend hospitalization (e.g., staged endovascular procedure, CABG);
• Administration of low molecular weight heparin (LMWH) within 8 hours of the procedure.

Intra-op Exclusion Criteria

• An introducer sheath with an overall length greater than 11 cm, or not 6 Fr or 7 Fr diameter;
• Femoral artery diameter less than 6 mm at access site;
• Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, "back wall stick", etc.);
• Angiographic evidence of more than minimal calcium, atherosclerotic disease, or stent within 1 cm of the puncture site;
• Overlapping Common Femoral Vein and Femoral Artery at access site;
• Placement of ipsilateral venous sheath during procedure;
• 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);
• More than one access site required;
• Loss of distal pulses in the ipsilateral extremity during the procedure;
• 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);
• Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula;
• Systemic hypertension (BP greater than 180/110 mmHg) or hypotension (BP less than 90/60 mmHg) prior to randomization;
• Length of the tissue tract, the distance between the anterior arterial wall and skin, is estimated to be less than 2.5 cm;
• 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.