Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System

Exclusion Criteria

• •1. Prior intra-aortic balloon pump at access site
• •2. Subjects with severe inflow disease (iliac artery diameter stenosis \> 50%) and/or severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed with prior standard of care Computed Tomography Imaging, duplex ultrasound, and/or intra-procedural fluoroscopy
• •3. Common femoral artery lumen diameter is \< 5 mm
• •4. In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
• •5. Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
• •6. Prior vascular surgery, vascular graft, or stent in region of access site
• •7. Subjects receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
• •8. Subjects with significant anemia
• •9. Subject with known bleeding disorder including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
• •10. Subject with renal insufficiency, on dialysis therapy, or with renal transplant
• •11. Known severe allergy to contrast reagent that cannot be managed with premedication
• •12. Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment
• •13. Planned anticoagulation therapy post-procedure such that the Activated Clotting Time (ACT) is expected to be elevated above 350 seconds for more than 24 hours after the procedure
• •14. Connective tissue disease (e.g., Marfan's Syndrome)
• •15. Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
• •16. Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
• •17. Subjects who are morbidly obese
• •18. Planned major intervention or surgery, including planned endovascular procedure in the target leg, within 30 days following the interventional procedure
• •19. Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed)
• •20. Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint
• •21. Known allergy to any device component
• •22. Subject is known or suspected to be pregnant or lactating
• •23. Evidence of active systemic or local groin infection
• •24. Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating
• •25. Subject is mentally incompetent or a prisoner
• •26. New York Heart Association (NYHA) Class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit within 24 hours prior to the index procedure
• •27. Left Ventricular Ejection Fraction (LVEF) \< 20%
• •28. Unilateral or bilateral lower extremity amputation
• •29. Known existing nerve damage in the target leg
• •30. Subjects who have already participated in this study
• •31. Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
• •32. Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
• •33. Ipsilateral femoral venous sheath during the catheterization procedure
• •34. Common femoral artery calcium, which is visible with prior Computed Tomography Imaging and/or duplex ultrasound
• •35. Subject in which there is difficulty inserting the introducer sheath or need for greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure
• •36. Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
• •37. Evidence of a pre-existing hematoma (\> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
• •38. Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior Computed Tomography imaging, fluoroscopy, and/or duplex ultrasound
• •39. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
• •40. Target arteriotomy \>18 French sheath