CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")

Stopped early · Not applicable

Conditions studied: Superficial Femoral Artery Stenosis

In brief

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 (together the "LifeStent® Vascular Stent System").

Key facts

Study ID

NCT00908947

Run by

C. R. Bard

People needed

173

Starts

2011-02-01

Expected to finish

2018-09-19

Last updated by the study team

2019-11-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Mission Cardiovascular Research Institute — Pleasanton, California, United States
• South Florida Medical Imaging, PA — Fort Lauderdale, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Loyola University Chicago — Chicago, Illinois, United States
• Heartland Vascular Center — Joliet, Illinois, United States
• Prairie Education and Research Cooperative (PERC) — Springfield, Illinois, United States
• Cardiovascular Research of Northwest Indiana, LLC. — Munster, Indiana, United States
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
• Kentucky Heart Foundation — Ashland, Kentucky, United States
• Steward St. Elizabeth Medical Center of Boston Inc. — Boston, Massachusetts, United States
• Metropolitan Hospital d/b/a Metro Health Hospital — Wyoming, Michigan, United States
• Midwest Aortic Vascular Institute P.C — North Kansas City, Missouri, United States
• The Cooper Health System — Camden, New Jersey, United States
• Saint Peter's University Hospital — New Brunswick, New Jersey, United States
• The Huntington Heart Center — Huntington, New York, United States
• Saint Vincent Consultants in Cardiovascular Diseases, LLC — Erie, Pennsylvania, United States
• Trustees of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States
• PinnacleHealth Cardiovascular Institute — Wormleysburg, Pennsylvania, United States
• South Carolina Heart Center, P.A. — Columbia, South Carolina, United States
• McLeod Regional Medical Center — Florence, South Carolina, United States
• Sanford Research — Sioux Falls, South Dakota, United States
• University Surgical Associates, LLC — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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