CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM") (NCT00908947) | Clinical Trial Compass
TerminatedNot Applicable
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
Stopped: Unable to enroll the required number of subjects
United States173 participantsStarted 2011-02
Plain-language 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 (together the "LifeStent® Vascular Stent System").
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
âś“. 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.
âś“. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
✓. The subject is ≥ 21 years old.
âś“. Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening.
âś“. 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 criteria
âś•. 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.
âś•. The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss.
âś•
What they're measuring
1
Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure.
Timeframe: 30-days and 12-months
2
Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure
Timeframe: At time of procedure (acute) and 12-months post-index procedure (Chronic)
. The subject has multiple stenoses or occlusions \> 240 mm.
âś•. 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.
âś•. The subject has a known contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, tantalum or sensitivity.
âś•. The subject has a known contraindication to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
âś•. The subject has a known history of bleeding diatheses or coagulopathy.