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

May 26, 2009
October 29, 2013
February 2011
September 2014   (final data collection date for primary outcome measure)
  • 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.

  • Freedom from death at 30 days and 12-months post procedure [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: Yes ]
  • Effectiveness: Freedom from device delivery failure and target lesion re-intervention (TLR) at 12-months post procedure. [ Time Frame: 12 months post procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00908947 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, amputation of the target limb, and thrombosis of target vess at 30-days post-procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, amputation of the target limb, and thrombosis of target vess at 30-days post-procedure [ Time Frame: 30 days and 12-months post procedure ] [ Designated as safety issue: Yes ]
  • Lesion Success [ Time Frame: time of placement ] [ Designated as safety issue: No ]
  • Procedure Success (acute) [ Time Frame: time of placement ] [ Designated as safety issue: No ]
  • Hemodynamic Success [ Time Frame: Index Procedure ] [ Designated as safety issue: No ]
  • Clinical Success (acute) [ Time Frame: discharge ] [ Designated as safety issue: No ]
  • walking distance [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • target limb revascularization at 12-months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target Lesion Patency at 12 months [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • Target Lesion Binary Restenosis at 12 months [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • Stent integrity at 12 months [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • Quality of Life Measurement [ Time Frame: 30-days and 12-months ] [ Designated as safety issue: No ]
  • Hemodynamic improvement at 12-months [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • Clinical improvement at 12-months [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • Definition of Improvement at 30-days and 12-months [ Time Frame: 30 days and 12-months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs

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").

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Superficial Femoral Artery Stenosis
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
Experimental: Overall Study
Subjects receiving PTA plus stenting with the LifeStent® Vascular Stent System.
Intervention: Device: PTA followed by placement of LifeStent® Vascular Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
234
September 2017
September 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00908947
BPV-08-001
Yes
C. R. Bard
C. R. Bard
Not Provided
Principal Investigator: Jeffrey P Carpenter, MD The Cooper Health System
Principal Investigator: Mark D Mewissen, MD Aurora Health Care
C. R. Bard
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP