| Eligibility |
Inclusion Criteria:
1. Age 21 or older
2. Scheduled for an elective or planned single percutaneous interventional
catheterization procedure involving access through the femoral artery using a
unilateral procedural sheath ID within the indicated range or device (OD) if an
expandable sheath is used
3. Willing and able to give written informed consent and to complete a follow-up visit at
30 ± 7 days
Exclusion Criteria:
Baseline
1. Evidence of current systemic bacterial or cutaneous infection, including groin
infection
2. Known bleeding disorders including thrombocytopenia (platelet count < 100,000),
thrombasthenia, hemophilia or Von Willebrand's disease or known Type II
heparin-induced thrombocytopenia
3. Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other
thrombin-specific anticoagulants planned within 24 hours prior to primary procedure
4. Glycoprotein IIb/IIIa inhibitors planned within 24 hours prior to the primary
procedure, during the procedure, or within 48 hours after the primary procedure
5. Planned anticoagulation therapy within 24 hours after the primary procedure such that
the activated clotting time (ACT) is expected to be elevated greater than 250 seconds
6. Significant anemia (hemoglobin less than 9 g/dL or hematocrit less than 27%)
7. Significant blood loss requiring transfusion of blood products within 30 days prior to
primary procedure
8. Documented left ventricular ejection fraction less than 20%
9. Renal insufficiency (glomerular filtration rate less than 30 ml/min or baseline serum
creatinine greater than 2.5 mg/dL) or on renal replacement therapy
10. Significant inflow disease (iliac or artery diameter stenosis greater than 50%) and/or
severe peripheral arterial disease (Rutherford Category 5 or 6), as confirmed with
pre-primary procedure CT angiography
11. Common femoral artery lumen diameter less than the indicated minimum based on
pre-primary procedure CT angiography
12. Evidence of marked tortuosity of the femoral or external iliac arteries in the target
leg, based on pre-primary procedure CT angiography
13. Evidence of arterial diameter stenosis (greater than 30%) within 15 mm proximal or
distal to arteriotomy site based on pre-primary procedure CT angiography
14. Evidence of anterior wall calcification of the target common femoral artery (other
than small, diffuse deposits which in the opinion of the Investigator will not impede
the vascular closure procedure) within 15 mm proximal or distal to arteriotomy site
based on pre-primary procedure CT angiography
15. Prior target artery closure with any closure device within 90 days prior to the
primary procedure, or closure with manual/mechanical compression within 30 days prior
to the primary procedure
16. Prior atherectomy, stent, vascular surgery, or vascular graph in the common femoral
artery of target leg
17. Known existing nerve damage in the target leg
18. Unsuitable for surgical repair of the target leg access site
19. Connective tissue disease (e.g., Marfan's Syndrome), or significant scarring of the
target access site which in opinion of the Investigator, would preclude use of the
investigational device in accordance with the IFU
20. Recent (within 60 days) cerebrovascular accident or Q-wave myocardial infarction
21. Morbidly obese or cachectic (BMI greater than 40 kg/m2 or less than 20 kg/m2)
22. Planned major intervention or surgery, including planned endovascular/catheter-based
procedure, in the target leg in the 30 days following the primary procedure
23. Ipsilateral or contralateral lower extremity amputation
24. Non-ambulatory (confined to bed or wheelchair)
25. Known allergy to any of the materials used in the LBC System (refer to Instructions
for Use)
26. Pregnant, lactating, or planning to become pregnant within 30 days following the
primary procedure
27. Would refuse blood transfusion if it were to be needed
28. Current enrollment in another investigational medical device or drug study
29. Previous participation in this study
30. Other medical, social, or psychiatric condition that in the opinion of the
Investigator would interfere with participation in the study
Intra-Procedural
1. Access site tissue tract (i.e., estimated distance from skin entry point to arterial
anterior surface at arteriotomy) expected to be greater than the indicated maximum
2. Initial common femoral arterial access for the primary procedure achieved with manual
palpation or blind arterial stick access, without use of an image guided approach
(ultrasound or angiography)
3. During arterial puncture for the primary procedure, the target femoral artery
suspected to have experienced a posterior arterial wall needle puncture or need for
greater than 2 ipsilateral arterial punctures
4. Primary procedural access site in the profunda femoris or superficial femoral artery
or the bifurcation of these vessels
5. Primary procedural access site located at the level or above the inferior epigastric
artery and/or above the inguinal ligament based on bony/arterial landmarks (above
femoral head on A-P projection)
6. Difficult dilation during initial target femoral artery access (e.g., that damages or
kinks dilators) while step-dilating up to the primary procedural sheath
7. Primary procedural access site is in a vascular graft
8. Primary procedural sheath ID greater than the indicated size, or primary procedural
device greater than the indicated size if an expandable sheath is used
9. Significant blood loss requiring transfusion of blood products during primary
procedure
10. Evidence of overt, actionable bleeding around the primary procedure sheath
11. Primary procedure sheath in place longer than 6 hours
12. Evidence of an acute hematoma (greater than 2 cm in diameter), arteriovenous fistula,
pseudoaneurysm, or intraluminal thrombosis at the primary procedure access site
13. Angiographic evidence of laceration, dissection or stenosis in the femoral artery that
would preclude use of the investigational device
14. Ipsilateral femoral venous sheath during the primary procedure
15. Activated clotting time (ACT) greater than the target immediately prior to primary
sheath removal and planned vascular closure or if ACT measurements are expected to be
greater than the target seconds within 24 hours after primary procedure
16. Uncontrolled hypertension (systolic blood pressure greater than the systolic maximum
or diastolic blood pressure greater than the diastolic maximum) at the time of primary
sheath removal and planned vascular closure
17. Systolic blood pressure less than the systolic minimum at the time of primary
procedural sheath removal and planned vascular closure
|
