CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs (CONTINUUM)
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
C. R. Bard
First received: May 26, 2009
Last updated: January 14, 2017
Last verified: January 2017
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").
Superficial Femoral Artery Stenosis
Device: PTA followed by placement of LifeStent® Vascular Stent
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs
Primary Outcome Measures:
- Freedom from occurrence of death at 30-days and 12-months post-index procedure. [ Time Frame: 30-days and 12-months ]
- The primary effectiveness endpoint of the study, device success, will collectively measure both acute and chronic effectiveness. [ Time Frame: Intra-procedure and 12-months post-index procedure ]
Successful contra-lateral delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length.
Primary Target Lesion Patency (TLP) at 12-months post-index procedure.
Secondary Outcome Measures:
- Freedom from TLR and/or TVR through 12-months post-index procedure. [ Time Frame: 12-months post-index procedure ]
- Secondary Device Success [ Time Frame: 30-days and 12-months post index-procedure ]
- Primary TLP (Sustained and Expanded) for Target Lesion Lengths > 160 mm at 12-, 24- and 36-months post-index procedure. [ Time Frame: 12-, 24-, and 36-months post-index procedure ]
- Freedom from TLR and/or TVR for Target Lesion Lengths > 160 mm at 12-, 24-, and 36-months post-index procedure. [ Time Frame: 12-, 24-, and 36-months post-index procedure ]
- Secondary Safety [ Time Frame: 30-days and 12-, 24-, and 36-months post-index procedure ]
- Acute Technical Success [ Time Frame: Intra-procedure ]
- Acute Lesion Success [ Time Frame: Intra-procedure ]
- Acute Procedure Success [ Time Frame: Intra-procedure ]
- Freedom from Fracture [ Time Frame: 12- and 24-months post-index procedure ]
- Sustained Freedom from TLR and/or TVR [ Time Frame: 24- and 36-months post-index procedure ]
- Sustained Hemodynamic Success [ Time Frame: 12-, 24-, and 36-months post-index procedure ]
- Acute Clinical Success [ Time Frame: Post-procedure ]
- Sustained Clinical Success [ Time Frame: 30-days and 12-, 24-, and 36-months post-index procedure ]
- Sustained TLP [ Time Frame: 24- and 36-months post-index procedure ]
- Expanded TLP [ Time Frame: 12-, 24- and 36-months post-index procedure ]
- Cumulative (primary-assisted and secondary) TLP [ Time Frame: 12-, 24-, and 36-months post-index procedure ]
- Quality of Life [ Time Frame: 30-days and 12-, 24- and 36-months post-index procedure ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2017 (Final data collection date for primary outcome measure)
Experimental: Overall Study
Subjects receiving PTA plus stenting with the LifeStent® Vascular Stent System.
Device: PTA followed by placement of LifeStent® Vascular Stent
PTA followed by placement of LifeStent® Vascular Stent
Other Name: LifeStent® Vascular Stent; LifeStent® XL Vascular Stent; LifeStent® SOLO(TM) Vascular Stent
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, occluded, restenosed, or re-occluded) in the infra-inguinal segment (SFA and/or proximal popliteal artery) that are amenable to treatment by PTA and stenting. All subjects enrolled in the study will receive PTA and stenting.
|Ages Eligible for Study:
||21 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00908947
C. R. Bard
||Jeffrey P Carpenter, MD
||The Cooper Health System
||Mark D Mewissen, MD
||Aurora Health Care
||C. R. Bard
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 26, 2009
||January 14, 2017
Keywords provided by C. R. Bard:
ClinicalTrials.gov processed this record on March 24, 2017