Status:
TERMINATED
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
Lead Sponsor:
C. R. Bard
Conditions:
Superficial Femoral Artery Stenosis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (tog...
Detailed Description
The study is a prospective, multi-center, single-arm, non-randomized study enrolling up to 234 subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) (stenosed, ...
Eligibility Criteria
Inclusion
- The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site.
- Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- The subject is ≥ 21 years old.
- Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening.
- The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category 2-4.
- The target lesion(s) has angiographic evidence of stenosis or restenosis ≥ 50% or occlusion (by visual estimate) and is amenable to PTA with stenting.
- The total target lesion(s) length must be ≤ 240 mm.
- The target vessel reference diameter is ≥ 4.0 mm and ≤ 6.5 mm (by visual estimate), and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.
Exclusion
- The subject is unable or unwilling to provide informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
- The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss.
- The subject has multiple stenoses or occlusions \> 240 mm.
- The subject has a previous stent or stent graft located in the target vessel.
- The subject has flow-limiting stenosis or occlusion of the inflow tract that cannot be adequately corrected (≤ 30% residual stenosis) prior to treatment of the target lesion(s). Investigator standard of care practices shall be utilized for treatment of inflow.
- The subject has a known contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, tantalum or sensitivity.
- The subject has a known contraindication to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
- The subject has a known history of bleeding diatheses or coagulopathy.
- The subject has concomitant renal failure with a creatinine of \> 2.5 mg/dL.
- The subject is currently on dialysis or receiving systemic immunosuppressive therapy.
- The subject has known concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus, septicemia or deep vein thrombosis at the time of the index procedure.
- The subject is currently participating in an investigational drug or another investigational device study that has not completed the primary endpoint, or that clinically interferes with the study endpoints. Note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- 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.
- The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath.
- The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
- There is angiographic evidence of unresolved thrombus at the target lesion(s) or within the target vessel that does not resolve with infusion of thrombolytics and/or mechanical thrombectomy (using an approved device) without adverse events/complications.
- The subject has undergone any non-iliac percutaneous intervention(s) \< 7 days prior to the index procedure.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2018
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00908947
Start Date
February 1 2011
End Date
September 19 2018
Last Update
November 19 2019
Active Locations (29)
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1
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
2
Mission Cardiovascular Research Institute
Pleasanton, California, United States, 94588
3
South Florida Medical Imaging, PA
Fort Lauderdale, Florida, United States, 33308
4
Baptist Hospital of Miami
Miami, Florida, United States, 33176