Bard® LifeStent® Vascular Stent Delivery System Study

NCT01179984 | Completed Results

• 1 other identifier: BPV-09-006
• Study Type: interventional
• Target: 76
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (2)

• Acute Effectiveness: Percentage of Stents With Successful Delivery

  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.

  At implantation (Day 0)

• (Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.

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

  30 day follow-up

Secondary Outcomes (1)

• Primary Target Lesion Patency

  12 months post-index procedure

Study Arms (1)

PTA and study stent

EXPERIMENTAL

Bard® LifeStent® Vascular Stent System

Device: Bard® LifeStent® Vascular Stent System

Interventions

Bard® LifeStent® Vascular Stent System DEVICE

Stent Implantation

PTA and study stent

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
• The subject is ≥ 21 years old.
• 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.
• The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).
• The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting.
• The total treated segment(s) must be ≤ 240 mm.
• 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.
• There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).

You may not qualify if:

• 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.
• The subject has claudication or critical limb ischemia described as Rutherford Category1 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss).
• The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum.
• The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
• The subject has a history of bleeding diatheses or coagulopathy.
• The subject has concomitant renal failure with a creatinine of \>2.5 mg/dL.
• The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
• The subject is receiving dialysis or immunosuppressive therapy.
• The subject is participating in an investigational drug or another investigational device study.
• 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.
• The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.
• 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).
• The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
• The subject is diagnosed with septicemia at the time of the study procedure.
• Patients with a stent previously implanted into the target vessel.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (8)

Univ. Prof. Dr. Johannes Lammer

Vienna, 1090, Austria

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

Dr. Henrik Schroeder

Berlin, 13347, Germany

Location

Dr. Hans Krankenberg

Hamburg, 22527, Germany

Location

Dr. Rainer Schmiedel

Kaiserslautern, 67657, Germany

Location

Prof. Dr. med. Dietrich Pfeiffer

Leipzig, 04103, Germany

Location

Prof. Dr. Holger Reinecke

Münster, 48149, Germany

Location

Prof. Dr. Gunnar Tepe

Rosenheim, 83022, Germany

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Associate Director of Clinical Affairs
• Organization: Bard Peripheral Vascular

josh.smale@crbard.com

480-379-2838

Study Officials

• Thomas Zeller, MD

  Herzzentrum Bad Krozingen, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: August 11, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2013
• Last Updated: November 8, 2018
• Results First Posted: March 9, 2017

Record last verified: 2018-10

Locations

AU (1); DE (7)