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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:
ClinicalTrials.gov Identifier:
NCT00908947
First Posted: May 27, 2009
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
C. R. Bard
  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
Superficial Femoral Artery Stenosis Device: PTA followed by placement of LifeStent® Vascular Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]
  • 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: 234
Study Start Date: February 2011
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908947


  Hide Study Locations
Locations
United States, California
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Mission Cardiovascular Research Institute
Pleasanton, California, United States, 94588
United States, Florida
South Florida Medical Imaging, PA
Fort Lauderdale, Florida, United States, 33308
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Baptist Hospital of Miami
Miami, Florida, United States, 33176
United States, Illinois
Loyola University Chicago
Chicago, Illinois, United States, 60637
Heartland Vascular Center
Joliet, Illinois, United States, 60435
Prairie Education and Research Cooperative (PERC)
Springfield, Illinois, United States, 62701
United States, Indiana
Cardiovascular Research of Northwest Indiana, LLC.
Munster, Indiana, United States, 46321
United States, Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States, 66160
United States, Kentucky
Kentucky Heart Foundation
Ashland, Kentucky, United States, 41101
United States, Massachusetts
Steward St. Elizabeth Medical Center of Boston Inc.
Boston, Massachusetts, United States, 02135
United States, Michigan
Metropolitan Hospital d/b/a Metro Health Hospital
Wyoming, Michigan, United States, 49509
United States, Missouri
Midwest Aortic Vascular Institute P.C
North Kansas City, Missouri, United States, 64116
United States, New Jersey
The Cooper Health System
Camden, New Jersey, United States, 08103
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New York
The Huntington Heart Center
Huntington, New York, United States, 11743
United States, Pennsylvania
Saint Vincent Consultants in Cardiovascular Diseases, LLC
Erie, Pennsylvania, United States, 16502
Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
PinnacleHealth Cardiovascular Institute
Wormleysburg, Pennsylvania, United States, 17043
United States, South Carolina
South Carolina Heart Center, P.A.
Columbia, South Carolina, United States, 29204
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
United States, South Dakota
Sanford Research
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
University Surgical Associates, LLC
Chattanooga, Tennessee, United States, 37403
United States, Texas
BCS Heart, LLP.
College Station, Texas, United States, 77845
Houston Center for Vascular Health
Houston, Texas, United States, 77030
The Methodist Hospital Research Institute dba Houston Methodist Research Institute
Houston, Texas, United States, 77030
United States, Wisconsin
Aurora Medical Group
Milwaukee, Wisconsin, United States, 53215
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

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00908947     History of Changes
Other Study ID Numbers: BPV-08-001
First Submitted: May 26, 2009
First Posted: May 27, 2009
Last Update Posted: May 16, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

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