Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System

Inclusion Criteria:

• patient/legal representative provides written informed consent
• Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure
• Target vessel has a lumen diameter ≥ 6 mm
• Patient must be willing to comply with follow-up requirements
• Patient has a 5-7F arterial puncture located in the common femoral artery

Exclusion Criteria:

• Arterial puncture in the femoral artery of both legs
• Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks
• Any closure system has been used on the ipsilateral arterial site within the previous 180 days
• Any reentry of the ipsilateral site is planned within the next 6 weeks
• History of surgical repair of blood vessels of the ipsilateral arterial site
• Patient is unable to ambulate at baseline

• Significant bleeding diathesis or platelet dysfunction

  1. Thrombocytopenia (Plt count ≤ 100,000)
  2. Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
  3. Hemophilia
  4. Von Willebrand"s disease
  5. Thrombophilia (i.e. factor 5 deficiency or other)
• ST-elevation myocardial infarction ≤ 48 hours prior to the cardiac or peripheral catheterization procedure
• Pre-existing severe non-cardiac systemic disease or pre-existing terminal illness
• Pre-existing systemic or cutaneous infection
• Receiving warfarin therapy within the last 14 days.
• INR results > 1.2 on day of procedure for any patient with a history of warfarin therapy
• Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
• Concurrent participation in another investigational device or drug trial
• Angiomax (bivalirudin) or other thrombin-specific anticoagulants or low molecular weight heparin ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
• Planned arterial access at the same access site ≤ 30 days following the femoral artery closure procedure
• Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure
• Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery
• Symptomatic leg ischemia in the target vessel limb including severe claudication or weak/absent pulse
• Absent of pedal pulse on ipsilateral side
• Pre-existing autoimmune disease
• BMI > 40 kg/m2
• The targeted femoral artery is tortuous or requires an introducer sheath length > 11 cm
• Fluoroscopically visible calcium, atherosclerotic disease, or stent ≤ 1 cm of the puncture site that would interfere with the placement of the VCD's plug
• Suspected bacterial contamination of access site
• Puncture through a vascular graft
• Double wall puncture
• Antegrade puncture
• Palpable Hematoma
• Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
• Any Arterial and/or Venous access on the ipsilateral or contralateral groin other than target study access site
• Patient is not cooperative
• Intra-procedural therapeutic thrombolysis is preformed
• Uncontrolled hypertension at time of sheath removal (blood pressure ≥ 170 mmHg systolic and/or ≥ 100mmHg diastolic)
• Peripheral vascular disease on the ipsilateral arterial vessel (≥ 50% stenosis) or aneurismal disease of this vessel.
• Sheaths has been changed during the procedure
• Heparinized patients with elevated pre-closure ACT level≥ 300 seconds
• Patient has known allergy to any materials used in the VCD
• Patient is known to require an extended hospitalization (e.g. patient is undergoing CABG surgery)
• Prior or recent use of an intra-aortic balloon pump through the arterial access site
• Cardiogenic shock (hemodynamic instability requiring intravenous medications or mechanical support) experienced during or immediately post-catheterization
• Patient is known or suspected to be pregnant, or is lactating
• Patient has known allergy to contrast medium
• Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the use of the VCD
• Required simultaneous ipsilateral or contralateral venous puncture