Bard® LifeStent® Vascular Stent Delivery System Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by C. R. Bard.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01179984
First received: May 21, 2010
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.


Condition Intervention
Peripheral Vascular Disease
Device: Bard® LifeStent® Vascular Stent System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bard® LifeStent® Vascular Stent Delivery System Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • (Deployment Success) Post-deployment stent length, measured during procedure directly at pre- and post-stent implantation time point [ Time Frame: At implantation (Day 0) ] [ Designated as safety issue: No ]

    Effectiveness:

    Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length.


  • (Safety) Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure. [ Time Frame: 30 day follow-up ] [ Designated as safety issue: Yes ]

    Safety:

    Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.



Secondary Outcome Measures:
  • Primary Target Lesion Patency [ Time Frame: 12 months post-index procedure ] [ Designated as safety issue: No ]
    Primary Target Lesion Patency (TLP) at 12 months post-index procedure compared to PTA.


Enrollment: 76
Study Start Date: June 2010
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Bard® LifeStent® Vascular Stent System
    Stent Implantation
Detailed Description:

Single-arm, non-randomized, prospective, multi-center study using the Bard® LifeStent® Vascular Stent Delivery System in subjects with lifestyle-limiting claudication or ischemic rest pain that are candidates for percutaneous transluminal angioplasty (PTA) and stenting with lesion(s) in the infra-inguinal segment (superficial femoral artery (SFA) and/or proximal popliteal artery). Subjects will be treated with PTA followed by implantation of the Bard® LifeStent® Vascular Stent.

Clinical follow-up for all subjects will be performed prior to hospital discharge, 30-days, and 12-, 24-, and 36-months post-index procedure.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with lifestyle-limiting claudication or ischemic rest pain that are candidates for percutaneous transluminal angioplasty (PTA) and stenting with lesion(s) in the infra-inguinal segment (superficial femoral artery (SFA) and/or proximal popliteal artery).

Criteria

Inclusion Criteria:

  1. The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
  2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
  3. The subject is ≥ 21 years old.
  4. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
  5. The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).
  6. The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting.
  7. The total treated segment(s) 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.
  9. There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).

Exclusion Criteria:

  1. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
  2. The subject has claudication or critical limb ischemia described as Rutherford Category1 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss).
  3. The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum.
  4. The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
  5. The subject has a history of bleeding diatheses or coagulopathy.
  6. The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
  7. The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
  8. The subject is receiving dialysis or immunosuppressive therapy.
  9. The subject is participating in an investigational drug or another investigational device study.
  10. 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 limited life expectancy of less than two years.
  11. The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.
  12. 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).
  13. The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
  14. The subject is diagnosed with septicemia at the time of the study procedure.
  15. Patients with a stent previously implanted into the target vessel.
  16. Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days. Note: One limb may be enrolled in the study, but only if the second limb is planned to be treated after the 30-day follow-up visit has taken place. The limb that may be enrolled has to be the limb with the more severe lesion and the reasons for treating this specific limb will need to be stated in the CRF.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179984

Locations
Austria
Univ. Prof. Dr. Johannes Lammer
Vienna, Austria, 1090
Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Baden Württemberg, Germany, 79189
Dr. Henrik Schroeder
Berlin, Germany, 13347
Dr. Hans Krankenberg
Hamburg, Germany, 22527
Dr. Rainer Schmiedel
Kaiserslautern, Germany, 67657
Prof. Dr. med. Dietrich Pfeiffer
Leipzig, Germany, 04103
Prof. Dr. Holger Reinecke
Münster, Germany, 48149
Prof. Dr. Gunnar Tepe
Rosenheim, Germany, 83022
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Thomas Zeller, MD Herzzentrum Bad Krozingen, Germany
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01179984     History of Changes
Other Study ID Numbers: BPV-09-006
Study First Received: May 21, 2010
Last Updated: February 13, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 21, 2014