Iliac Artery Occlusive DiseaseLuminexxNCT00561457
A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
A study testing Bard Luminexx Iliac Stent and Delivery System in people with Iliac Artery Occlusive Disease, run by C. R. Bard.
Trial summary
To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iliac Artery Occlusive Disease
- What is being tested?
- Bard Luminexx Iliac Stent and Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Jan 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient or legal guardian understands procedure and provides written informed consent prior to study participation.
- Patient must be able and willing to comply with all study procedures including scheduled follow-up visits and diagnostic tests.
- Lesion(s) distinctly localized in the common and/or external iliac arteries.
- Reference lumen diameter (RLD) 6 mm and 9 mm.
- Stenosis 30% and symptomatic ischemic disease (Category 1-6 Chronic Limb Ischemia or Threatened or Irreversible Acute Limb Ischemia).
Who cannot join
- Patients diagnosed with preoperative coagulation disorder or with contraindications to antiplatelet or anticoagulant therapy.
- Patients who are pregnant or planning to become pregnant during the clinical investigation.
- Patients with a life expectancy < 3 years.
- Patients currently or scheduled to be enrolled in another investigation that conflicts with follow-up testing or may confound the study data.
- Patients with absolute contraindication to x-ray contrast media or medications normally administered during an interventional procedure.
- Patients with severe tortuosity or angulation of a vessel that may prevent access in the opinion of the investigator.
- The presence of soft, thrombotic or embolic material within or adjacent to the lesion(s) being treated with the study device, in the opinion of the investigator.
About this study
To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease
Read the detailed description
The study is designed to collect safety and efficacy data on the Bard Luminexx Iliac Stent in a broad patient population having indications for iliac stenting. Effectiveness in this study will be demonstrated by the prevention of Major Adverse Clinical Events (MACE). The composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (>50%) at nine months.
- Conditions
- Iliac Artery Occlusive Disease
- Being tested
- Bard Luminexx Iliac Stent and Delivery System
- Keywords
- Iliac, Artery, Occlusive, Stenosis
- Medical subject headings
- Bites and Stings, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bard Luminexx Iliac Stent and Delivery SystemDevice
Iliac Stenting
| Study group | Role | What they receive |
|---|---|---|
| Iliac Stenting | Experimental | Stent placement in the iliac artery Receives: Device: Bard Luminexx Iliac Stent and Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Clinical Events (MACE)
Major Adverse Clinical Events defined as peri-procedural death (death during the procedure or prior to hospital discharge), target lesion revascularization (TLR), or stented segment restenosis (> 50%) at nine months postprocedure.
Measured: 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startJun 2003
- Primary completionJan 2008
- Study completionJan 2008
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 Iliac Artery Occlusive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561457
- Sponsor's protocol ID
- BPV-1021
- Acronym
- Luminexx
- Status last verified
- Jan 2017
- First submitted
- 20 Nov 2007
- Last updated
- 1 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
- ClinicalTrials.gov ID
- NCT00561457
- Acronym / sponsor ID
- Luminexx / BPV-1021
- Conditions
- Iliac Artery Occlusive Disease
- Keywords
- Iliac, Artery, Occlusive, Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Posted 4 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease
Detailed description
The study is designed to collect safety and efficacy data on the Bard Luminexx Iliac Stent in a broad patient population having indications for iliac stenting. Effectiveness in this study will be demonstrated by the prevention of Major Adverse Clinical Events (MACE). The composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (>50%) at nine months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iliac Stenting | Experimental | Device: Bard Luminexx Iliac Stent and Delivery SystemStent placement in the iliac artery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient or legal guardian understands procedure and provides written informed consent prior to study participation.
- Patient must be able and willing to comply with all study procedures including scheduled follow-up visits and diagnostic tests.
- Lesion(s) distinctly localized in the common and/or external iliac arteries.
- Reference lumen diameter (RLD) 6 mm and 9 mm.
- Stenosis 30% and symptomatic ischemic disease (Category 1-6 Chronic Limb Ischemia or Threatened or Irreversible Acute Limb Ischemia).
Key exclusion criteria (7 listed)
- Patients diagnosed with preoperative coagulation disorder or with contraindications to antiplatelet or anticoagulant therapy.
- Patients who are pregnant or planning to become pregnant during the clinical investigation.
- Patients with a life expectancy < 3 years.
- Patients currently or scheduled to be enrolled in another investigation that conflicts with follow-up testing or may confound the study data.
- Patients with absolute contraindication to x-ray contrast media or medications normally administered during an interventional procedure.
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 Luminexx Iliac Stent and Delivery SystemIliac Stenting | Device | Iliac Stenting |
Primary outcome
Rate of Major Adverse Clinical Events (MACE)
Time frame: 9-months
Major Adverse Clinical Events defined as peri-procedural death (death during the procedure or prior to hospital discharge), target lesion revascularization (TLR), or stented segment restenosis (> 50%) at nine months postprocedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bard Luminexx Iliac Stent and Delivery System in people with Iliac Artery Occlusive Disease, run by C. R. Bard.
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 5 inclusion and 7 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 May 2011). 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?
Rate of Major Adverse Clinical Events (MACE) (time frame: 9-months). 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 1 Mar 2017.