A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY)

NCT01920308 | Completed

• 1 other identifier: BPV-13-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the deliverability, clinical utility and effectiveness of the 5 mm diameter size offering of the LifeStent® Vascular Stent

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

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

  30 day data can be collected via telephone screening. TLR is defined as a revascularization procedure (e.g. PTA (percutaneous transluminal angioplasty), cryoplasty, etc.) of the target lesion. TVR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) of the target vessel outside the target lesion.

  30 days

• Technical success, defined as successful deployment and placement accuracy based upon a rating scale completed by the investigators at time of index procedure. Book-end sizes will be evaluated for clinical utility of size range.

  30 days

Secondary Outcomes (2)

• Secondary Safety defined as freedom from death (after 30 days)

  Through 12 months post procedure

• Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) after 30 days and 12 months post-index procedure.

  Through 12 months

Study Arms (1)

5 mm Bard LifeStent Vascular Stent

The study population will be comprised of subjects who present with moderate lifestyle-limiting claudication to mild tissue loss (Rutherford Category 2-5) that are candidates for PTA and stenting. Subjects with lesion(s) in the infra-inguinal segment (SFA and/or popliteal artery) will be considered for enrollment. The reference vessel diameter will be appropriate for treatment with available stent diameter of 5.0 mm (by visual estimate).

Device: 5 mm Bard LifeStent Vascular Stent

Interventions

5 mm Bard LifeStent Vascular Stent DEVICE

The LifeStent® Vascular Stent is a peripheral stent intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.

Also known as: Bard LifeStent Vascular Stent System, SFA stenting

5 mm Bard LifeStent Vascular Stent

Eligibility Criteria

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

Study Population

A prospective observational study of the Bard® LifeStent® Vascular Stents in the treatment of symptomatic de novo or restenotic lesions.

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 moderate lifestyle-limiting claudication to mild tissue loss defined as: Rutherford Category1 2-5 (moderate claudication to minor tissue loss
• The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion in the SFA and/or popliteal artery (by visual estimate) and is amenable to PTA and stenting
• The target vessel reference diameter will be (by visual estimate) appropriate for treatment with available stent diameter of 5.0 mm
• A total of two stents may be used to cover lesions. Overlapping is allowed
• 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 0 (asymptomatic), 1 ( mild claudication), 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 (1)

University Heart Centre Bad Krozingen

Bad Krozingen, 79187, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Thomas Zeller, Prof. Dr.

  University Heart Centre in Bad Krozingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 9, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2015
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

DE (1)