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Peripheral Arterial DiseaseREALITY IIINCT03071146

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

An observational study of Peripheral Arterial Disease and Intermittent Claudication, 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 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Bard® LifeStent® 5F Vascular Stent System
Type of treatment
Medical device
How many people
30 participants
Where
4 sitesGermany
Study dates
15 Feb 2017to 31 May 2018
Phase
Observational
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

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).

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 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).

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 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.
Show all 20Show 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 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).
  • The subject has angiographic evidence of large acute thrombus at the target lesion.
  • 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(s) will not come into contact with the previously placed stent during treatment of the target lesion.
  • Lesion requiring the use of more than two stents.
  • Bilateral disease in the native SFA and/or 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 telephone screening 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 case report form (CRF).
  • The subject had a prior vascular intervention within 30 days before, or has an intervention planned for within 30 days after the index procedure. Note: Additional non-target lesions may be treated during the index procedure.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Universitaets-Herzzentrum Freiburg, Klinik fuer Kardiologie und Angiologie II

    Bad Krozingen, Suedring 15, 79189

  • Gemeinschaftspraxis fuer Radiologie

    Berlin, Heinz-Galinski-Str. 1, 13347

  • Fuerst-Stirum-Klinik Bruchsal

    Bruchsal, Gutleutstr. 1-14, 76646

  • Praxis fuer Interventionelle Angiologie

    Kaiserslautern, Strassburger Allee 4, 67657

Other trials in Germany

About this study

Official title: A Prospective Study of the Performance of the Bard LifeStent 5F Vascular Stent System

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.

Being tested
Bard® LifeStent® 5F Vascular Stent System
Medical subject headings
Peripheral Arterial Disease, Intermittent Claudication

What participants receive

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

  • Bard® LifeStent® 5F Vascular Stent SystemDevice

    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.

Study groups in NCT03071146
Study groupRoleWhat they receive
Bard® LifeStent® 5F Vascular Stent SystemPatients 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.
Receives: Device: Bard® LifeStent® 5F Vascular Stent System

What is being measured

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

  1. Freedom from occurrence of death

    Measured: 30 days post-index procedure

  2. Freedom from occurrence of amputation

    Measured: 30 days post-index procedure

  3. Freedom from TLR (Target Lesion Revascularization)

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

    Measured: 30 days post-index procedure

  4. 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.

    Measured: 30 days post-index procedure

  5. 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.

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

Secondary outcomes (10)

  1. Freedom from TLR (Target Lesion Revascularization)

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

    Measured: Up to 12 months post-index procedure

  2. 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.

    Measured: Up to 12 months post-index procedure

  3. Primary patency rates

    Patency is defined as a reduction in luminal diameter (stenosis) of <=50% and of <=70% measured by Duplex ultrasound (DUS) (peak systolic velocity ratio or PSVR <= 2.4 and <=3.4). Failure of primary patency is defined as a restenosis (reduction in luminal diameter of >50%) as measured by DUS (PSVR >2.4).

    Measured: Up to 12 months post-index procedure

  4. Freedom from death

    TLR is defined as a revascularization procedure (e.g. PTA, 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.

    Measured: 12 months post-index procedure

  5. Freedom from occurrence of stroke

    Measured: 12 months post-index procedure

  6. Freedom from occurrence of MI (myocardial infarction)

    Measured: 12 months post-index procedure

  7. Occurrence of emergent surgical revascularization of the target limb

    Measured: 12 months post-index procedure

  8. Occurrence of significant distal embolization in target limb

    Measured: 12 months post-index procedure

  9. Occurrence of target limb major amputation

    Measured: 12 months post-index procedure

  10. Occurrence of thrombosis of target vessel

    Measured: 12 months post-index procedure.

Timeline

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

  1. First posted6 Mar 2017
  2. Study start15 Feb 2017
  3. Primary completion4 May 2017
  4. Study completion31 May 2018

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03071146
Sponsor's protocol ID
BPV-16-004
Acronym
REALITY III
Status last verified
Aug 2018
First submitted
21 Feb 2017
Last updated
21 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease and Intermittent Claudication, 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 20 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 21 Aug 2018. 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?

Freedom from occurrence of death (time frame: 30 days post-index procedure). The study lists 5 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 NCT03071146.

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 21 Aug 2018.

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