Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)

Inclusion criteria

• Over 18 years of age.
• Each patient, or his or her guardian or legal representative, is willing to give informed consent.
• Clinically indicated for an intra-arterial procedure involving access through the common femoral artery and conducted through an access sheath size of between 6F and 7F inclusive.

Exclusion criteria

• Patients with known allergy to any of the materials used in the device.
• Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.
• Evidence of systemic bacterial or cutaneous infection, including groin infection.
• Patients suffering with definitive or potential coagulopathy or platelet count <100,000./µl
• Use of systemic thrombolytic agents within 24 hours prior to or during the catheterization procedure which cause the concentration of fibrinogen to be < 100 mg/dl or if post-thrombolytic fibrinogen (in case of thrombolysis within 24 hours or intra-procedural) cannot be measured.
• Patients in whom an introducer sheath smaller than 6F or greater than 7F have been used.
• Currently participating in another investigational device or drug study.
• Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%, or previous bypass surgery or stent placement in the vicinity of the access site.
• If puncture site is via a vascular graft.
• If a palpable haematoma is observed during the procedure.
• Patients in whom there is any indication that puncture has been made in the profunda femorals artery or superficial femoral artery, or adjacent to the bifurcation.
• Patients with a common femoral artery lumen diameter of less than 5 mm.
• Patients that have any amputation from an access site limb.
• Patients that have undergone a percutaneous procedure using a vascular closure device for hemostasis within the previous 30 days or using manual/mechanical pressure for hemostasis within the prior 30 days in the same leg.
• Patients with a systolic blood pressure reading below 90 mmHg.
• Patients with an active haematoma, arteriovenous fistula, or pseudoaneurysm.
• Patients with a very superficial artery where the depth from skin to the artery surface at the access site is less than 4 mm.
• Morbidly obese patients (Body Mass Index >35kg/m2).
• Patients with a stent less than or equal to 1 cm of the puncture site that would interfere with placement of the device implant.
• Patient is know or suspected to be pregnant, or is lactating.
• Patients in whom there has been an antegrade puncture.
• Patients in whom there has been difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial wall puncture.
• Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site.
• Patients with uncontrolled hypertension (BP greater than or equal to 180/110mmHg) at time of vascular closure
• Patients with acute ST-elevation myocardial infarction less than or equal to 48hours before catheterization procedure.
• Patients with cardiogenic shock (hemodynamic instability requiring intravenous medication or mechanical support) experienced during or immediately post-catheterization.
• Patients who are unable to ambulate at baseline.
• Patients known to require an extended hospitalization (e.g. patient is undergoing cardiac surgery).
• Patient has already participated in the trial.
• Patient is unavailable for follow up.

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