RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System

A Post-Market, Prospective, Multi-Center, Study to Evaluate Safety and Efficacy of the StarClose™ Vascular Closure System in Patients Who Are Ambulated Early Post-Diagnostic Catheterization

To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure.

To evaluate the StarClose™ VCS in the femoral artery in subjects who are ambulated early post-percutaneous cardiac or peripheral vascular, diagnostic catheterization procedure. The clinical use of vascular closure devices for rapid hemostasis after femoral access was first reported in 1991. 18 participants may be ambulated almost immediately after diagnostic coronary angiography and discharged many hours earlier than currently practiced in most centers utilizing a supine restriction period of 6 hours after diagnostic catheterization.14 After coronary interventions, participant comfort is additionally increased by immediate sheath removal.

This early ambulation study is an evaluation of a clip-based technology, which achieves vascular hemostasis with the use of a novel extravascular Nitinol clip to provide an immediate mechanical closure that does not depend upon the body's clotting system. The procedures will be performed in participants who meet specific entrance criteria.

Inclusion:

• Subject must be 18-85.
• Subject must be an acceptable candidate for an elective,non-emergent diagnostic procedure performed percutaneously via the common femoral artery through either a 5F or 6F procedural sheath.
• Subject is an acceptable candidate for emergent vascular surgery.
• Subject agrees to follow-up evaluations to assess for complications related to femoral access site.
• If among the 50 ultrasound sub-study Subjects enrolled,Subject agrees to have an ultrasound of femoral artery performed post-procedure during the 30 ± 7 days follow-up visit.
• Subject or legal representative has been informed of the nature of the study and agrees to provisions and has provided written informed consent as approved by the Institutional Review Board of respective clinical site.

Exclusion:

• History of bleeding diathesis or coagulopathy including hemophilia, von Willebrand's disease, and/or a current, known platelet count <100,000 cells/mm3, or baseline INR > 1.7.
• Body Mass Index (BMI) ³ 35 kg/m2.
• Presence of significant anemia (Hgb < 10 g/dL, Hct < 30%).
• Advanced Subject refusal of blood transfusions, should transfusion become necessary.
• Participation in another trial of an investigational drug or device that has not yet completed follow-up requirements.
• Pregnant or lactating female.
• Clinically severe peripheral vascular disease in the ipsilateral limb, defined as severe claudication (walking < 100 feet), weak or absent pulses, or lower extremity vascular graft.
• History of ipsilateral femoral arterial puncture within previous three months or history of vascular closure device deployment in ipsilateral femoral artery at any time.
• Subject has unilateral or bilateral lower extremity amputation(s).
• Subject is unable to routinely walk at least 20 feet without assistance.
• Subject has an active systemic or cutaneous infection or inflammation.
• Subject has a pre-existing severe non-cardiac systemic disease or illness with a life expectancy of < 30 days.
• Subject has already participated in this Study.
• Subject has known allergy to nitinol.

Access Site Exclusion-(*Evaluated via Limited Femoral Angiogram)

• Pseudoaneurysm or AV fistula present in ipsilateral femoral artery prior to arterial closure.*
• Puncture distal to the common femoral artery bifurcation or above the inguinal ligament which is typically defined by the inferior border of the inferior epigastric artery on sheath angiogram or the upper third of the femoral head by plain fluoroscopy.*
• The arterial lumen diameter at the arteriotomy site is < 5mm by visual estimate.*
• Angiographic evidence of calcified lesions at the arteriotomy site.*
• Difficulty inserting the introducer sheath at the start of the catheterization procedure due to vessel scarring or tortuosity, or anterior/posterior wall femoral artery punctures or greater than 2 ipsilateral arterial puncture attempts at the time of the percutaneous procedure.
• Known iliac or femoral stenosis >50% or previous bypass surgery or stent placement in the vicinity of the puncture site.
• Planned percutaneous procedure (diagnostic or intervention) in ipsilateral femoral artery prior to the 30-day follow-up evaluation.
• Subject has intra-procedural bleeding around the access site.
• Presence or previous use of an intra-aortic balloon pump through the existing arterial puncture site.

Procedural Exclusion:

• Low molecular weight heparin administration within 8 hours of enrollment.
• For cases where anticoagulants are used, ACT level > 350 seconds at time of enrollment.
• Subject is determined to require treatment that will extend hospitalization (e.g. ---Subject is undergoing CABG surgery or staged PTCA).
• Persistent hypertension (SBP >180 or DBP >110 mm Hg) unresponsive to medical -therapy at time of enrollment.
• Placement of an ipsilateral femoral venous sheath during procedure.
• Presence of clinically significant hematoma (> 6 cm) in ipsilateral femoral artery prior to arterial closure.
• Placement of introducer sheath < 5F or > 6F during procedure.