Utility, Safety, and Effectiveness of the Bard LifeStent 5F Vascular Stent System

NCT03071146 | Completed

• 1 other identifier: BPV-16-004
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD). PAD is generally associated with blocked arteries of the legs. The superficial femoral artery (SFA) and popliteal artery are common locations for this problem to develop. The patient may experience pain or discomfort in the leg that occurs when walking or have other complications associated with wound healing. The purpose of this study is to collect information to assess the deliverability, clinical utility, safety and effectiveness of the Bard® LifeStent® 5F Vascular Stent System.

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Outcome Measures

Primary Outcomes (5)

• Freedom from occurrence of death

  30 days post-index procedure

• Freedom from occurrence of amputation

  30 days post-index procedure

• Freedom from TLR (Target Lesion Revascularization)

  TLR is defined as a revascularization procedure (e.g. PTA, cryoplasty, etc.) of the target lesion.

  30 days post-index procedure

• Freedom from TVR (Target Vessel Revascularization)

  TVR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) of the target vessel outside the target lesion.

  30 days post-index procedure

• Technical success

  Technical success is defined as successful deployment and placement accuracy based upon a rating scale completed by the investigators. bookend sizes will be evaluated for clinical utility of size range.

  At the time of index procedure (usually within 10 minutes)

Secondary Outcomes (10)

• Freedom from TLR (Target Lesion Revascularization)

  Up to 12 months post-index procedure

• Freedom from TVR (Target Vessel Revascularization)

  Up to 12 months post-index procedure

• Primary patency rates

  Up to 12 months post-index procedure

• Freedom from death

  12 months post-index procedure

• Freedom from occurrence of stroke

  12 months post-index procedure

Study Arms (1)

Bard® LifeStent® 5F Vascular Stent System

Patients with lesion(s) in the infra-inguinal segment (SFA and/or popliteal artery) will be treated with percutaneous transluminal angioplasty (PTA) and the Bard® LifeStent® 5F Vascular Stent System.

Device: Bard® LifeStent® 5F Vascular Stent System

Interventions

Bard® LifeStent® 5F Vascular Stent System 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.

Bard® LifeStent® 5F Vascular Stent System

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

This study will be conducted among patients who are candidates for PTA and stenting with lesion(s) in the infra-inguinal segment (SFA and/or popliteal artery).

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 of age.
• The subject has lifestyle-limiting claudication to mild tissue loss defined as: Rutherford Category 2-5 (moderate claudication to minor tissue loss).
• The target lesion(s) has angiographic evidence of a hemodynamically relevant stenosis or restenosis ≥50% or occlusion of 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 diameters of 5.0, 6.0 and 7.0 mm.
• A total of two stents may be used to treat a target lesion. 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 Category 0 (asymptomatic), 1 (mild claudication), or 6 (major tissue loss).
• The subject has a known contraindication (including allergic reaction) or sensitivity to nickel, titanium or tantalum.
• The subject has a known allergy of hypersensitivity to contrast media which cannot be adequately pre-medicated.
• The subject has a known uncontrolled blood coagulation/bleeding disorder.
• 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 diagnosed with septicemia at the time of the study procedure.
• 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 noncompliant with the protocol, confound the data interpretation, or is associated with limited life expectancy not sufficient to complete all study procedures.
• The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.
• The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
• The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
• The subject has severe calcification of the target lesion, which prevents inflation of a PTA balloon (pre-dilatation of the target lesion is required).

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (4)

Fuerst-Stirum-Klinik Bruchsal

Bruchsal, Gutleutstr. 1-14, 76646, Germany

Location

Gemeinschaftspraxis fuer Radiologie

Berlin, Heinz-Galinski-Str. 1, 13347, Germany

Location

Praxis fuer Interventionelle Angiologie

Kaiserslautern, Strassburger Allee 4, 67657, Germany

Location

Universitaets-Herzzentrum Freiburg, Klinik fuer Kardiologie und Angiologie II

Bad Krozingen, Suedring 15, 79189, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Zeller, MD

  Universitaets-Herzzentrum Freiburg, 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: February 21, 2017
• First Posted: March 6, 2017
• Study Start: February 15, 2017
• Primary Completion: May 4, 2017
• Study Completion: May 31, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)