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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00908947
First received: May 26, 2009
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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").


Condition Intervention Phase
Superficial Femoral Artery Stenosis
Device: PTA followed by placement of LifeStent® Vascular Stent
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Freedom from occurrence of death at 30-days and 12-months post-index procedure. [ Time Frame: 30-days and 12-months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Secondary Device Success [ Time Frame: 30-days and 12-months post index-procedure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Secondary Safety [ Time Frame: 30-days and 12-, 24-, and 36-months post-index procedure ] [ Designated as safety issue: Yes ]
  • Acute Technical Success [ Time Frame: Intra-procedure ] [ Designated as safety issue: No ]
  • Acute Lesion Success [ Time Frame: Intra-procedure ] [ Designated as safety issue: No ]
  • Acute Procedure Success [ Time Frame: Intra-procedure ] [ Designated as safety issue: Yes ]
  • Freedom from Fracture [ Time Frame: 12- and 24-months post-index procedure ] [ Designated as safety issue: No ]
  • Sustained Freedom from TLR and/or TVR [ Time Frame: 24- and 36-months post-index procedure ] [ Designated as safety issue: No ]
  • Sustained Hemodynamic Success [ Time Frame: 12-, 24-, and 36-months post-index procedure ] [ Designated as safety issue: No ]
  • Acute Clinical Success [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]
  • Sustained Clinical Success [ Time Frame: 30-days and 12-, 24-, and 36-months post-index procedure ] [ Designated as safety issue: No ]
  • Sustained TLP [ Time Frame: 24- and 36-months post-index procedure ] [ Designated as safety issue: No ]
  • Expanded TLP [ Time Frame: 12-, 24- and 36-months post-index procedure ] [ Designated as safety issue: No ]
  • Cumulative (primary-assisted and secondary) TLP [ Time Frame: 12-, 24-, and 36-months post-index procedure ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 30-days and 12-, 24- and 36-months post-index procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 234
Study Start Date: February 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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, 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
  3. The subject is ≥ 21 years old.
  4. Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening.
  5. The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category 2-4.
  6. The target lesion(s) has angiographic evidence of stenosis or restenosis ≥ 50% or occlusion (by visual estimate) and is amenable to PTA with stenting.
  7. The total target lesion(s) length must be ≤ 240 mm.
  8. 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:

  1. 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.
  2. The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss.
  3. The subject has multiple stenoses or occlusions > 240 mm.
  4. The subject has a previous stent or stent graft located in the target vessel.
  5. 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.
  6. The subject has a known contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, tantalum or sensitivity.
  7. The subject has a known contraindication to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
  8. The subject has a known history of bleeding diatheses or coagulopathy.
  9. The subject has concomitant renal failure with a creatinine of > 2.5 mg/dL.
  10. The subject is currently on dialysis or receiving systemic immunosuppressive therapy.
  11. The subject has known concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus, septicemia or deep vein thrombosis at the time of the index procedure.
  12. 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.
  13. 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.
  14. The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath.
  15. 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).
  16. 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.
  17. The subject has undergone any non-iliac percutaneous intervention(s) < 7 days prior to the index procedure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908947

Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Jeffrey P Carpenter, MD The Cooper Health System
Principal Investigator: Mark D Mewissen, MD Aurora Health Care
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00908947     History of Changes
Other Study ID Numbers: BPV-08-001
Study First Received: May 26, 2009
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
SFA
Stent
Popliteal
infrainguinal
LifeStent
Peripheral
Arterial

ClinicalTrials.gov processed this record on April 15, 2014