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BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease (BOLSTER)

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ClinicalTrials.gov Identifier: NCT02228564
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Peripheral Vascular Disease Arterial Occlusive Disease Procedure: Percutaneous transluminal angioplasty (PTA) Device: LIFESTREAM™ covered stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)
Study Start Date : September 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: LIFESTREAM™
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Procedure: Percutaneous transluminal angioplasty (PTA)
Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Device: LIFESTREAM™ covered stent
Implantation of the LIFESTREAM™ covered stent




Primary Outcome Measures :
  1. Composite Success [ Time Frame: Evaluation through 9 months post-index procedure ]
    The occurrence of device and/or procedure related death or myocardial infarction through 30 days, or any Target Lesion Revascularization, target limb(s) major amputation, or restenosis through 9-months post-index procedure. These events will be assessed by clinical evaluations.


Secondary Outcome Measures :
  1. Major Adverse Events (MAEs) [ Time Frame: Evaluation through 9 months post index procedure ]
    Major Adverse Events (MAEs) will be assessed by clinical evaluations.

  2. Acute Lesion Success [ Time Frame: Assessed at the conclusion of the Index-procedure ]
    Acute lesion success will be assessed by a clinical evaluation.

  3. Acute Procedure Success [ Time Frame: Assessed prior to the subject being discharged from the hospital which occurs the same day as the procedure ]
    Acute Procedure Success assessed by clinical evaluations.

  4. Acute Technical Success [ Time Frame: Assessed after completion of the index procedure ]
    Acute Technical Success assessed by clinical evaluations.

  5. Target Lesion Revascularization (TLR) [ Time Frame: Assessed through 36 months post index procedure. ]
    TLR assessed by clinical evaluations.

  6. Target Vessel Revascularization (TVR) [ Time Frame: Assessed through 36-months post index procedure. ]
    TVR assessed by clinical evaluations.

  7. Sustained Clinical Success [ Time Frame: Assessed through 36-months post index procedure. ]
    Sustained Clinical Success assessed by clinical evaluations.

  8. Primary Patency [ Time Frame: Assessed through 36-months post index procedure. ]
    Primary Patency assessed by clinical evaluations.

  9. Primary Assisted Patency [ Time Frame: Assessed through 36-months post index procedure. ]
    Primary Assisted Patency assessed by clinical evaluations.

  10. Secondary Patency [ Time Frame: Assessed through 36-months post index procedure. ]
    Secondary Patency assessed by clinical evaluations.

  11. Quality of Life - Walking Impairment Questionnaire [ Time Frame: Assessed through 36-months post index procedure. ]
    Quality of Life assessed by clinical evaluations.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

CLINICAL INCLUSION CRITERIA:

  • The subject provides written informed consent using an Informed Consent Form approved by the Ethics Committee/ Institutional Review Board for the site.
  • Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
  • Subject is a male or non-pregnant female ≥ 21 years old with an expected lifespan sufficient to allow for completion of all study procedures.
  • Subject has intermittent claudication (Rutherford Category 2-3) or ischemic rest pain (Rutherford Category 4).
  • Subject is able and willing to comply with any required medication regimen.

ANGIOGRAPHIC INCLUSION CRITERIA:

  • Subject has evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion in the native common and/or external iliac artery that is ≥ 50% stenosed (including total occlusions).
  • The target lesion can be successfully crossed with a guide wire and pre-dilated with an appropriately sized PTA balloon.
  • The reference vessel diameter is between 4.5 mm -12.0 mm in diameter.
  • The target lesion is ≤ 100 mm in combined length (per side).
  • The subject has angiographic evidence of a patent (< 50% stenosis) profunda and/or superficial femoral artery (SFA) in the target limb.

CLINICAL EXCLUSION CRITERIA:

  • The subject is unable or unwilling to provide written informed consent or to conform to the study protocol follow-up procedures and visits.
  • The subject is or plans to become pregnant during the study.
  • The subject is asymptomatic, has mild claudication or critical limb ischemia with tissue loss described as Rutherford Category 0, 1, 5 or 6.
  • The subject has a vascular graft previously implanted in the native iliac vessel.
  • The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA) within 3 months prior to the index procedure.
  • The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
  • The subject has a serum creatinine ≥ 2.5 mg/dl or is on dialysis.
  • The subject has a known allergy or sensitivity to stainless steel (i.e., Nickel), ePTFE, or has intolerance to the antiplatelet, anticoagulant or thrombolytic medications required per the protocol.
  • The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
  • The subject had a prior vascular intervention within 30 days before or planned for within 30 days after the index procedure.
  • The subject has another medical condition, which 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 is currently participating in an investigational drug, biologic, or another device study.

ANGIOGRAPHIC EXCLUSION CRITERIA:

  • The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath. The ipsilateral common femoral artery should be patent (< 50% stenosis).
  • The target lesion requires treatment other than angioplasty to facilitate subject device delivery.
  • The subject has severe calcification of the target lesion, preventing inflation of PTA balloon.
  • The target lesion has been previously treated with a stent (bare or covered).
  • The subject has angiographic evidence of acute thrombus at the target lesion.
  • The target lesion involves the origin of the internal iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude the side branch.
  • The target lesion located in the distal external iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude side branches or be exposed to compressive forces associated with the close proximity to the common femoral artery.
  • The subject has an abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion.
  • The subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to the initiation of the treatment for this study.

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): NCT02228564


Locations
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United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
Vascular and Interventional Specialists of Orange County
Orange, California, United States, 91107
UC Davis Cardiovascular Medicine
Sacramento, California, United States, 95817
United States, Florida
Florida Research Network
Gainesville, Florida, United States, 32605
Baptist Medical Center
Jacksonville, Florida, United States, 32207
Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
Mount Sinai Medical Center
Miami, Florida, United States, 33140
United States, Massachusetts
University of Massachusetts Worcester
Worcester, Massachusetts, United States, 01655
United States, Missouri
Kansas City Vascular Foundation
Kansas City, Missouri, United States, 64116
United States, North Carolina
CaroMont Regional Medical Center
Gastonia, North Carolina, United States, 28054
North Carolina Heart and Vascular
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
Donald Guthrie Foundation
Sayre, Pennsylvania, United States, 18840
United States, Texas
Univeristy of Texas Medical Branch
Galveston, Texas, United States, 77550
United States, Washington
Swedish Health Services
Seattle, Washington, United States, 98122
Germany
Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH
Bad Krozingen, Germany, 79189
Ev.Krankenhaus Königin Elisabeth
Berlin, Germany, 10365
Praxis fur Interventionelle Angiologie
Kaiserslautern, Germany, 67657
Universitaetsklinikum Leipzig
Leipzig, Germany, 04289
Bonifatius Hospital
Lingen, Germany, 49808
New Zealand
Auckland Hospital
Auckland, New Zealand
Sponsors and Collaborators
C. R. Bard
Investigators
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Principal Investigator: John R Laird, M.D. U. C. Davis Medical Center

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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02228564     History of Changes
Other Study ID Numbers: BPV-12-001
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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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:
Lack of perfusion in the extremities
Atherosclerosis
Intermittent claudication
BOLSTER
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis