Peripheral Vascular DiseaseNCT01179984
Bard® LifeStent® Vascular Stent Delivery System Study
A study testing Bard® LifeStent® Vascular Stent System in people with Peripheral Vascular Disease, run by C. R. Bard at 8 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Bard® LifeStent® Vascular Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jun 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).
- The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting.
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- The total treated segment(s) must be ≤ 240 mm.
- The target vessel reference diameter is ≥4.0 mm and ≤6.5 mm (by visual estimate) and therefore appropriate for treatment with available stent diameters of 6.0 mm 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 Category1 1 (mild claudication), 5 (minor tissue loss) 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.
- 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 visit 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
8 sites in 2 countries.
8 sites in 2 countries
Germany7 sites
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 79189
Dr. Henrik Schroeder
Berlin, 13347
Dr. Hans Krankenberg
Hamburg, 22527
Dr. Rainer Schmiedel
Kaiserslautern, 67657
Prof. Dr. med. Dietrich Pfeiffer
Leipzig, 04103
Prof. Dr. Holger Reinecke
Münster, 48149
Prof. Dr. Gunnar Tepe
Rosenheim, 83022
About this study
The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.
Read the detailed description
Single-arm, non-randomized, prospective, multi-center study using the Bard® LifeStent® Vascular Stent Delivery System in subjects with lifestyle-limiting claudication or ischemic rest pain that are candidates for percutaneous transluminal angioplasty (PTA) and stenting with lesion(s) in the infra-inguinal segment (superficial femoral artery (SFA) and/or proximal popliteal artery). Subjects will be treated with PTA followed by implantation of the Bard® LifeStent® Vascular Stent.
Clinical follow-up for all subjects will be performed prior to hospital discharge, 30-days, and 12-, 24-, and 36-months post-index procedure.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Bard® LifeStent® Vascular Stent System
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bard® LifeStent® Vascular Stent SystemDevice
Stent Implantation
| Study group | Role | What they receive |
|---|---|---|
| PTA and study stent | Experimental | Bard® LifeStent® Vascular Stent System Receives: Device: Bard® LifeStent® Vascular Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Effectiveness: Percentage of Stents With Successful Delivery
Effectiveness:
Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length.
Measured: At implantation (Day 0)
(Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.
Safety:
Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.
Measured: 30 day follow-up
Secondary outcomes (1)
Primary Target Lesion Patency
Percentage of participants with Primary Target Lesion Patency (TLP) at 12 months post-index procedure
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.
- First posted11 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, MD, Principal investigator, Herzzentrum Bad Krozingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179984
- Sponsor's protocol ID
- BPV-09-006
- Status last verified
- Oct 2018
- First submitted
- 21 May 2010
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bard® LifeStent® Vascular Stent Delivery System Study
- ClinicalTrials.gov ID
- NCT01179984
- Acronym / sponsor ID
- BPV-09-006
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Posted 9 Mar 2017
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 evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.
Detailed description
Single-arm, non-randomized, prospective, multi-center study using the Bard® LifeStent® Vascular Stent Delivery System in subjects with lifestyle-limiting claudication or ischemic rest pain that are candidates for percutaneous transluminal angioplasty (PTA) and stenting with lesion(s) in the infra-inguinal segment (superficial femoral artery (SFA) and/or proximal popliteal artery). Subjects will be treated with PTA followed by implantation of the Bard® LifeStent® Vascular Stent.
Clinical follow-up for all subjects will be performed prior to hospital discharge, 30-days, and 12-, 24-, and 36-months post-index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTA and study stent | Experimental | Device: Bard® LifeStent® Vascular Stent SystemBard® LifeStent® Vascular Stent System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).
Key exclusion criteria (16 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 1 (mild claudication), 5 (minor tissue loss) 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 |
|---|---|---|
| Bard® LifeStent® Vascular Stent SystemStent Implantation | Device | PTA and study stent |
Primary outcome
Acute Effectiveness: Percentage of Stents With Successful Delivery
Time frame: At implantation (Day 0)
Effectiveness: Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length.
(Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.
Time frame: 30 day follow-up
Safety: Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.
1 secondary outcome
Primary Target Lesion Patency
Time frame: 12 months post-index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MD principal investigator
Herzzentrum Bad Krozingen, Germany
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bard® LifeStent® Vascular Stent System in people with Peripheral Vascular Disease, run by C. R. Bard at 8 sites in 2 countries.
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 16 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acute Effectiveness: Percentage of Stents With Successful Delivery (time frame: At implantation (Day 0)). 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 8 Nov 2018.