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Peripheral Artery DiseaseREALITY2NCT02262949

A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System

A study testing LifeStent Vascular Stent in people with Peripheral Artery Disease, run by C. R. Bard at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the deliverability, clinical utility, safety and effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Peripheral Artery Disease
What is being tested?
LifeStent Vascular Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
4 sitesGermany
Study dates
Sep 2014to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 mild tissue loss defined as: Rutherford Category1 2-5 (moderate claudication to minor tissue loss).
  • The target lesion 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 is (by visual estimate) appropriate for treatment with available stent diameters of 6.0 and 7.0 mm.
  • There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).

Who cannot join

  • 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 antiplatelet/anticoagulant medication, 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 of coagulopathy.
  • The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
Show all 17Show fewer
  • 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 noncompliant 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 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 is diagnosed with septicemia at the time of the study procedure.
  • Subjects with a stent previously implanted into the target lesion. A target vessel with a previously placed stent is permitted as long as the subject device will not come into contact with the previously placed stent during treatment of the target lesion.
  • Lesions requiring the use of more than one investigational stent.
  • 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.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • University Heart Centre Freiburg

    Bad Krozingen, 79189

  • Gemeinschaftspraxis für Radiologie

    Berlin, 13347

  • Fürst Stirum Klinik Bruchsal

    Bruchsal, 76646

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022

Other trials in Germany

About this study

Official title: A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System (REALITY2)

The purpose of this study is to assess the deliverability, clinical utility, safety and effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.

Being tested
LifeStent Vascular Stent
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LifeStent Vascular StentDevice

    PTA followed by implantation of the LifeStent Vascular Stent (stent length 250 mm) in the SFA or popliteal artery.

Study groups in NCT02262949
Study groupRoleWhat they receive
LifeStent Vascular StentExperimentalThis is a single arm study and all subjects receive PTA and implantation of one Life Stent Vascular Stent.
Receives: Device: LifeStent Vascular Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Events (MAEs)

    Occurence of death or target limb amputation or any target lesion revascularization/target vessel revascularization through 30 days post-index procedure. These events will be assessed by clinical evaluations.

    Measured: 30 days

  2. Stent performance

    Stent deployment success; defined as a post-deployment stent length deviating <10% from pre-deployment stent length (determined by an independent core lab).

    Placement accuracy based upon a rating scale completed by the investigator at time of index procedure.

    Measured: intra operative

Secondary outcomes (3)

  1. Major Adverse Events (MAEs)

    Occurence of death, stroke, MI, emergent surgical revascularization of the target limb, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 12 months post-index procedure. These events will be assessed by clinical evaluations.

    Measured: 1 year

  2. Target lesion/vessel revascularization

    TLR/TVR rate after 12 months post-index procedure. TLR/TVR will be assessed by clinical evaluations.

    Measured: 1 year

  3. Target lesion patency

    Primary patency (PSVR<2.4) rate at 12 month post-index procedure (measured by DUS). Patency will be assessed by clinical evaluations.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJul 2015
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02262949
Sponsor's protocol ID
BPV-13-002
Other IDs
DRKS00006281
Acronym
REALITY2
Status last verified
Dec 2016
First submitted
25 Sep 2014
Last updated
7 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing LifeStent Vascular Stent in people with Peripheral Artery Disease, run by C. R. Bard at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Events (MAEs) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02262949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.

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