A Prospective, Multi-Center, Non-Randomized, SinGle-Arm Study of the BDTM Low ProfILe Vascular Covered Stent in PerIpheral ArTerY Disease (AGILITY)
Greg Westin
Primary Investigator
Brief description of study
The purpose of this study is to provide clinical evidence for safety, effectiveness and clinical benefit of the BD Low Profile Vascular Covered Stent System (LPVCS). The BD LPVCS wil be used to treat stenosis and occlusion in the common and/or external iliac and/or superficial femoral / proximal popliteal arteries to reduce symptoms of peripheral artery disease.
Detailed description of study
The BD™ LPVCS study is a prospective, multi-center, non-randomized, single-arm Investigational
Device Exemption (IDE) study intended to collect evidence of the safety and effectiveness of the
BD™ LPVCS investigational device for the treatment of stenosis and occlusion in the common
and/or external iliac artery and superficial femoral artery (SFA)/proximal popliteal artery (PPA).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Peripheral artery disease
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Age: 18 years - 100 years
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Gender: All
Clinical Inclusion Criteria
To be eligible to participate in this study, a subject must meet all of the following criteria:
1. The subject provides written informed consent using an Informed Consent Form
(ICF) that is reviewed and approved by the Ethics Committee (EC) / Institutional
Review Board (IRB) for the site.
2. The subject agrees to comply with the protocol-mandated follow-up procedures
and visits.
3. The subject is a male or non-pregnant female ≥ 21 years old with an expected
lifespan sufficient to allow for completion of all study procedures. Female
subjects of childbearing potential must have a negative pregnancy test (urine or
blood) prior to the index procedure.
4. The subject is able and willing to comply with any required medication regimen.
Clinical Exclusion Criteria
Subjects are excluded from the study if any of the following criteria apply:
1. The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA)
within three (3) months prior to the index procedure.
2. The subject has a known, uncorrectable bleeding diathesis or active
coagulopathy or severe thrombocytopenia (platelet count 3. The subject has serum creatinine ≥ 2.5 mg/dl or is currently on dialysis.
4. The subject has a known allergy or sensitivity to Tantalum and Nitinol (i.e.,
Nickel, Titanium), ePTFE, or has intolerance to the antiplatelet, anticoagulant,
or thrombolytic medications required per the protocol.
5. The subject has a known allergy or sensitivity to contrast media, which cannot
be adequately pre-medicated.
6. The subject has another medical condition, which, in the opinion of the
Investigator, may cause him/her to be non-compliant with the protocol,
confound the data interpretation, or is associated with a life expectancy
insufficient to allow for the completion of study procedures and follow-up.
7. The subject is currently participating in an investigational drug, biologic, or
device study. Studies requiring extended follow-up for products that are now
commercially available are not considered investigational studies.The subject requires a concomitant surgical procedure (e.g., endarterectomy
followed by stenting).
9. A non-index procedure planned intervention within 30 days of the index
procedure or a planned intervention 30 days post-index procedure.
10. Prior or planned major amputation (of either limb
