Peripheral Artery DiseaseREALITYNCT01920308
A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY)
An observational study of Peripheral Artery Disease, run by C. R. Bard at 1 site in Germany.
Trial 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 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?
- 5 mm Bard LifeStent Vascular Stent
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Jul 2015
- 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: A prospective observational study of the Bard® LifeStent® Vascular Stents in the treatment of symptomatic de novo or restenotic lesions.
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 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
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- 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
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 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
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- 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
- Lesions requiring the use of more than two stents
- 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. 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 CRF
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 5 mm Bard 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.
5 mm Bard LifeStent Vascular StentDevice
Also called Bard LifeStent Vascular Stent System, SFA stenting
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: 5 mm Bard LifeStent Vascular Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (2)
Secondary Safety defined as freedom from death (after 30 days)
Secondary Safety defined as freedom from death (after 30 days), stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 12 months post-index procedure.
Measured: 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.
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: Through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, Prof. Dr., Principal investigator, University Heart Centre in Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920308
- Sponsor's protocol ID
- BPV-13-001
- Acronym
- REALITY
- Status last verified
- Nov 2016
- First submitted
- 8 Aug 2013
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY)
- ClinicalTrials.gov ID
- NCT01920308
- Acronym / sponsor ID
- REALITY / BPV-13-001
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 mm Bard LifeStent Vascular Stent | – | Device: 5 mm Bard LifeStent Vascular StentThe 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective observational study of the Bard® LifeStent® Vascular Stents in the treatment of symptomatic de novo or restenotic lesions.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 mm Bard LifeStent Vascular StentAlso: Bard LifeStent Vascular Stent System, SFA stentingThe 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. | Device | 5 mm Bard LifeStent Vascular Stent |
Primary outcome
Freedom from occurrence of death, amputation and TLR/TVR at 30 days post-index procedure.
Time frame: 30 days
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.
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.
Time frame: 30 days
2 secondary outcomes
Secondary Safety defined as freedom from death (after 30 days)
Time frame: 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.
Time frame: Through 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Zeller, Prof. Dr. principal investigator
University Heart Centre in Bad Krozingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by C. R. Bard at 1 site 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 9 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 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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, amputation and TLR/TVR at 30 days post-index procedure. (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?
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 10 Nov 2016.