| Eligibility |
Inclusion Criteria:
- Candidate for elective or planned (i.e., not emergent or urgent) percutaneous
transcatheter valve replacement (TAVR) via a 10-20F device or sheath (12-25F OD) with
common femoral artery approach
- Vessel size would allow for access for the MANTA VCD based on vessel size as
determined by baseline CTA: minimum vessel diameter of 5mm for the 14F MANTA VCD and
6mm for the 18F MANTA VCD
- Understand and sign the study specific written informed consent form and PHI
authorization
- Able and willing to fulfill the follow-up requirements
Exclusion Criteria:
- Patients known to be pregnant or lactating
- Patients who have a systemic infection or a local infection at or near the access site
- Patients with significant anemia (hemoglobin =10 g/DL)
- Patients who are morbidly obese or cachectic (BMI >40 or <20kg/m2)
- Patients with a known bleeding disorder including thrombocytopenia (platelet count
<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
- Patients with allergy to bovine materials or any other device material, including
collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or
nickel
- Patients with a femoral artery puncture in target groin within the prior 30 days,
prior vascular closure device placement in the target common femoral artery within 3
months, or any prior target femoral artery access-related complication
- Patients who have undergone use of an intra-aortic balloon pump (IABP) through the
arterial access site within 30 days prior to the baseline evaluation.
- Patients who have a Common Femoral Artery (CFA) with visible calcium and/or
tortuosity, as determined by baseline CTA, precluding safe access and likely to
interact with large bore access site arteriotomy, determined by investigator.
- Patients with previous iliofemoral intervention in region of access site, including
but not limited to prior atherectomy, stenting, surgical or grafting procedures in the
access area
- Patients in whom oral anticoagulation therapy cannot be stopped for the peri
procedural period or patients with INR >1.8 at the time of the procedure
- Patients who are unable to ambulate at least 6 meters without assistance at baseline
- Patients with renal insufficiency (serum creatinine >2.5 mg/dl) or on dialysis therapy
- Patients with existing nerve damage in the ipsilateral leg
- Patients with a further planned endovascular procedure within the next 30 days
- Patients who have already participated in this IDE study
- Patients who are currently participating in another clinical study of an unapproved
investigational device or drug that has not concluded the follow-up period or patient
currently participating in another clinical study likely to influence hemostasis and
vascular complications
- Patients who cannot adhere to or complete the investigational protocol for any reason
including but not limited to geographical residence, psychiatric condition or life
threatening disease
- Patients who have a common femoral artery <5mm in diameter for the 14F MANTA VCD or <6
mm in diameter for the 18F MANTA VCD, common femoral artery stenosis resulting in a
vessel diameter <5mm in diameter for the 14F MANTA VCD or <6 mm in diameter for the
18F MANTA VCD, or > 50% diameter femoral or iliac artery stenosis
- Patients in whom, during initial access of the artery, arteriotomy and surrounding
anatomy cannot be visualized and identified clearly under U/S imaging and/or if the
vertical depth from the surface of the skin to target area of the common femoral
artery measures greater than 6cm
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