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: May 12, 2017
Last verified: May 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: No masking
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:
||November 2017 (Final data collection date for primary outcome measure)
Experimental: Overall Study
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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||May 12, 2017
|Studies a U.S. FDA-regulated Drug Product:
|Studies a U.S. FDA-regulated Device Product:
|Device Product Not Approved or Cleared by U.S. FDA:
Keywords provided by C. R. Bard:
ClinicalTrials.gov processed this record on May 25, 2017