Clinical Investigation for Safety and Efficacy Study of CELT ACD Arterial Closure Device

Inclusion Criteria:

1. Over 18 years of age.

2. Each patient, or his or her guardian or legal representative, is willing to give
informed consent.

3. 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:

1. Patients with known allergy to any of the materials used in the device.

2. Severe acute non-cardiac systemic disease or terminal illness with a life expectancy
of less than one year.

3. Evidence of systemic bacterial or cutaneous infection, including groin infection.

4. Patients suffering with definitive or potential coagulopathy or platelet count
<100,000./µl

5. Use of systemic thrombolytic agents within 24 hours prior to or during the
catheterisation 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.

6. Patients in whom an introducer sheath smaller than 6F or greater than 7F have been
used.

7. Currently participating in another investigational device or drug study.

8. 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.

9. If puncture site is via a vascular graft.

10. If a palpable haematoma is observed during the procedure.

11. 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.

12. Patients with a common femoral artery lumen diameter of less than 5 mm.

13. Patients that have any amputation from an access site limb.

14. 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.

15. Patients with a systolic blood pressure reading below 90 mmHg.

16. Patients with an active haematoma, arteriovenous fistula, or pseudoaneurysm.

17. Patients with a very superficial artery where the depth from skin to the artery
surface at the access site is less than 4 mm.

18. Morbidly obese patients (Body Mass Index >35kg/m2).

19. Patients with a stent less than or equal to 1 cm of the puncture site that would
interfere with placement of the device implant.

20. Patient is know or suspected to be pregnant, or is lactating.

21. Patients in whom there has been an antegrade puncture.

22. Patients in whom there has been difficulty in obtaining vascular access resulting in
multiple arterial punctures and/or posterior arterial wall puncture.

23. Patients who have undergone prior or recent use of an intra-aortic balloon pump
through the arterial access site.

24. Patients with uncontrolled hypertension (BP greater than or equal to 180/110mmHg) at
time of vascular closure

25. Patients with acute ST-elevation myocardial infarction less than or equal to 48hours
before catheterization procedure.

26. Patients with cardiogenic shock (hemodynamic instability requiring intravenous
medication or mechanical support) experienced during or immediately
post-catherization.

27. Patients who are unable to ambulate at baseline.

28. Patients known to require an extended hospitalization (e.g. patient is undergoing
cardiac surgery).

29. Patient has already participated in the trial.

30. Patient is unavailable for follow up.