Superficial Femoral Artery StenosisCONTINUUMNCT00908947
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
A study testing PTA followed by placement of LifeStent® Vascular Stent in people with Superficial Femoral Artery Stenosis, run by C. R. Bard at 29 sites in United States.
Trial summary
The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (together the "LifeStent® Vascular Stent System"). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Superficial Femoral Artery Stenosis
- What is being tested?
- PTA followed by placement of LifeStent® Vascular Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 29 sitesUnited States
- Study dates
- Feb 2011to 19 Sep 2018
- 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 provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site.
- Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- The subject is ≥ 21 years old.
- Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening.
- The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category 2-4.
- The target lesion(s) has angiographic evidence of stenosis or restenosis ≥ 50% or occlusion (by visual estimate) and is amenable to PTA with stenting.
- The total target lesion(s) length 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.
Who cannot join
- The subject is unable or unwilling to provide informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
- The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss.
- The subject has multiple stenoses or occlusions > 240 mm.
- The subject has a previous stent or stent graft located in the target vessel.
- The subject has flow-limiting stenosis or occlusion of the inflow tract that cannot be adequately corrected (≤ 30% residual stenosis) prior to treatment of the target lesion(s). Investigator standard of care practices shall be utilized for treatment of inflow.
- The subject has a known contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, tantalum or sensitivity.
Show all 17Show fewer
- The subject has a known contraindication to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
- The subject has a known history of bleeding diatheses or coagulopathy.
- The subject has concomitant renal failure with a creatinine of > 2.5 mg/dL.
- The subject is currently on dialysis or receiving systemic immunosuppressive therapy.
- The subject has known concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus, septicemia or deep vein thrombosis at the time of the index procedure.
- The subject is currently participating in an investigational drug or another investigational device study that has not completed the primary endpoint, or that clinically interferes with the study endpoints. Note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- 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 a life expectancy insufficient to allow for the completion of study procedures and follow-up.
- The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude 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).
- There is angiographic evidence of unresolved thrombus at the target lesion(s) or within the target vessel that does not resolve with infusion of thrombolytics and/or mechanical thrombectomy (using an approved device) without adverse events/complications.
- The subject has undergone any non-iliac percutaneous intervention(s) < 7 days prior to the index procedure.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Kentucky Heart Foundation
Ashland, Kentucky, 41101
Steward St. Elizabeth Medical Center of Boston Inc.
Boston, Massachusetts, 02135
The Cooper Health System
Camden, New Jersey, 08103
University Surgical Associates, LLC
Chattanooga, Tennessee, 37403
Loyola University Chicago
Chicago, Illinois, 60637
BCS Heart, LLP.
College Station, Texas, 77845
South Carolina Heart Center, P.A.
Columbia, South Carolina, 29204
Saint Vincent Consultants in Cardiovascular Diseases, LLC
Erie, Pennsylvania, 16502
McLeod Regional Medical Center
Florence, South Carolina, 29501
South Florida Medical Imaging, PA
Fort Lauderdale, Florida, 33308
Houston Center for Vascular Health
Houston, Texas, 77030
The Methodist Hospital Research Institute dba Houston Methodist Research Institute
Houston, Texas, 77030
The Huntington Heart Center
Huntington, New York, 11743
Heartland Vascular Center
Joliet, Illinois, 60435
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Baptist Hospital of Miami
Miami, Florida, 33176
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Cardiovascular Research of Northwest Indiana, LLC.
Munster, Indiana, 46321
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Midwest Aortic Vascular Institute P.C
North Kansas City, Missouri, 64116
Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
Mission Cardiovascular Research Institute
Pleasanton, California, 94588
Sanford Research
Sioux Falls, South Dakota, 57104
Prairie Education and Research Cooperative (PERC)
Springfield, Illinois, 62701
PinnacleHealth Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043
Metropolitan Hospital d/b/a Metro Health Hospital
Wyoming, Michigan, 49509
About this study
The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (together the "LifeStent® Vascular Stent System").
Read the detailed description
The study is a prospective, multi-center, single-arm, non-randomized study enrolling up to 234 subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) (stenosed, occluded, restenosed, or re-occluded) in the infra-inguinal segment (Superficial femoral artery [SFA] and/or proximal popliteal artery) that are amenable to treatment by percutaneous transluminal angioplasty (PTA) and stenting. All subjects enrolled in the study will receive PTA and stenting.
- Conditions
- Superficial Femoral Artery Stenosis
- Being tested
- PTA followed by placement of LifeStent® Vascular Stent
- Keywords
- SFA, Stent, Popliteal, infrainguinal, LifeStent, Peripheral, Arterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA followed by placement of LifeStent® Vascular StentDevice
Also called LifeStent® Vascular Stent; LifeStent® XL Vascular Stent; LifeStent® SOLO(TM) Vascular Stent
PTA followed by placement of LifeStent® Vascular Stent
| Study group | Role | What they receive |
|---|---|---|
| Overall Study | Experimental | PTA plus stenting with the LifeStent® Vascular Stent System Receives: Device: PTA followed by placement of LifeStent® Vascular Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure.
Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure.
Measured: 30-days and 12-months
Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure
The primary effectiveness endpoint of the study, device success, collectively measured both acute and chronic effectiveness.
Acute effectiveness is defined as successful delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length.
Chronic effectiveness is defined as Primary Target Lesion Patency (TLP) at 12-months post-index procedure, as measured by Duplex Ultrasound (DUS).
Measured: At time of procedure (acute) and 12-months post-index procedure (Chronic)
Secondary outcomes (17)
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure.
Target Lesion Revascularization (TLR) is defined as the interval following the index procedure until the first revascularization procedure of the target lesion. Target Vessel Revascularization (TVR) is defined as the interval following the index procedure until the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel.
Measured: 12-months post-index procedure
Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm.
- Primary Safety (freedom from occurrence of death at 30-days and 12-months post-index procedure) of the Target Lesion Lengths > 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.
Measured: 30-days and 12-months Post -Index Procedure
Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm.
Primary Effectiveness (Device Success) of Target Lesion Lengths > 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.
Measured: 12-months Post-Index Procedure
Freedom From Fracture at 12 and 24-Months Post-Index Procedure
Freedom from Fracture (FFF) at 12- and 24-months post-index procedure.
Measured: 12- and 24-months post-index procedure
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
Primary Target Lesion Patency (TLP) - Sustained and Expanded - for Target Lesion Lengths > 160 mm at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Ratio (PSR) values of < 2.0, <2.5, and < 3.0.
Measured: 12, 24, and 36 months Post Index Procedure
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm.
Freedom from Target Lesion Revascularization (TTR) and/or Target Vessel Revascularization (TRV) for Target Lesion Lengths > 160 mm at 12-, 24- and 36-months post-index procedure.
Measured: 12-, 24-, and 36-months post-index procedure
Secondary Safety Endpoint: Freedom From Composite Adverse Events
Secondary Safety (Freedom from Composite Adverse Events) is defined as freedom from death (excluding 30-days and 12-months post-index procedure), stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 30-days and 12-, 24-, and 36-months post-index procedure.
Measured: 30-days and 12-, 24-, and 36-months post-index procedure
Number of Stents Deployed With Acute Technical Success
Acute technical success is defined as successful deployment of the stent to the intended location.
Measured: Intra-procedure
Number of Acute Lesion Success
Acute lesion success is defined as attainment of ≤ 30% residual stenosis of the target lesion using any percutaneous method and/or non-investigational device (i.e., post-dilatation) based on angiographic data.
Measured: Intra-procedure
Number of Procedures With Acute Success
Acute procedure success is defined as lesion success and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel).
Measured: Intra-procedure
Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure
Sustained Freedom from Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24- and 36-months post-index procedure.
Measured: 24- and 36-months post-index procedure
Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure
Sustained hemodynamic success is defined as sustained improvement of Ankle-Brachial Index (ABI) from baseline value of ≥ 0.15 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated Target Lesion Revascularization (TLR) in surviving subjects.
Measured: 30 days, 12-, 24-, and 36-months post-index procedure
Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure
Sustained clinical success is defined as sustained cumulative improvement from baseline value of ≥ 1 category according to Rutherford et al.12 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated TLR in surviving subjects.
Measured: 30-days and 12-, 24-, and 36-months post-index procedure
Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure
Sustained Target Lesion Patency (TLP) was measured at 24- and 36-months post-index procedure corresponding to PSR < 2.5.
Measured: 24- and 36-months post-index procedure
Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure
Expanded TLP was measured at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) < 3.0.
Measured: 12, 24, and 36 months Post-Index Procedure
Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
Cumulative (primary-assisted and secondary) Target Lesion Patency (TLP) was measured at 12-, 24-, and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) < 2.5, and PSR < 3.0.
Measured: 12, 24, and 36 Months Post-Index Procedure
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
The Walking Impairment Questionnaire (WIQ) evaluation scale values range from 0 to 100, with 0 meaning inability to complete the specific task and 100 representing no difficulty in completing the task. A higher score (mean) represents an improvement in walking abilities compared to baseline measure. The results below represent, for each item measured (pain, walking distance, walking speed, and stair climbing), the mean difference between the score observed at Baseline and those observed at 30-days, 12-, 24-, and 36-months post-index procedure.
Measured: 30-days, and 12-, 24-, and 36-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 posted27 May 2009 (estimated)
- Study startFeb 2011
- Primary completion18 Sep 2018
- Study completion19 Sep 2018
Why it stopped: Unable to enroll the required number of subjects
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 Superficial Femoral Artery StenosisStudies 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
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey P Carpenter, MD, Principal investigator, Cooper Norcross HealthMark D Mewissen, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908947
- Sponsor's protocol ID
- BPV-08-001
- Acronym
- CONTINUUM
- Status last verified
- Nov 2019
- First submitted
- 26 May 2009
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
- ClinicalTrials.gov ID
- NCT00908947
- Acronym / sponsor ID
- CONTINUUM / BPV-08-001
- Conditions
- Superficial Femoral Artery Stenosis
- Keywords
- SFA, Stent, Popliteal, infrainguinal, LifeStent, Peripheral, Arterial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll the required number of subjects
- Enrolment
- 173 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Posted 6 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (together the "LifeStent® Vascular Stent System").
Detailed description
The study is a prospective, multi-center, single-arm, non-randomized study enrolling up to 234 subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) (stenosed, occluded, restenosed, or re-occluded) in the infra-inguinal segment (Superficial femoral artery [SFA] and/or proximal popliteal artery) that are amenable to treatment by percutaneous transluminal angioplasty (PTA) and stenting. All subjects enrolled in the study will receive PTA and stenting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Study | Experimental | Device: PTA followed by placement of LifeStent® Vascular StentPTA plus stenting with the 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 (8 listed)
- The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site.
- Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- The subject is ≥ 21 years old.
- Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening.
- The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category 2-4.
Key exclusion criteria (17 listed)
- The subject is unable or unwilling to provide informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
- The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss.
- The subject has multiple stenoses or occlusions > 240 mm.
- The subject has a previous stent or stent graft located in the target vessel.
- The subject has flow-limiting stenosis or occlusion of the inflow tract that cannot be adequately corrected (≤ 30% residual stenosis) prior to treatment of the target lesion(s). Investigator standard of care practices shall be utilized for treatment of inflow.
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 |
|---|---|---|
| PTA followed by placement of LifeStent® Vascular StentAlso: LifeStent® Vascular Stent; LifeStent® XL Vascular Stent; LifeStent® SOLO(TM) Vascular StentPTA followed by placement of LifeStent® Vascular Stent | Device | Overall Study |
Primary outcome
Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure.
Time frame: 30-days and 12-months
Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure.
Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure
Time frame: At time of procedure (acute) and 12-months post-index procedure (Chronic)
The primary effectiveness endpoint of the study, device success, collectively measured both acute and chronic effectiveness. Acute effectiveness is defined as successful delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length. Chronic effectiveness is defined as Primary Target Lesion Patency (TLP) at 12-months post-index procedure, as measured by Duplex Ultrasound (DUS).
17 secondary outcomes
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure.
Time frame: 12-months post-index procedure
Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm.
Time frame: 30-days and 12-months Post -Index Procedure
Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm.
Time frame: 12-months Post-Index Procedure
Freedom From Fracture at 12 and 24-Months Post-Index Procedure
Time frame: 12- and 24-months post-index procedure
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
Time frame: 12, 24, and 36 months Post Index Procedure
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm.
Time frame: 12-, 24-, and 36-months post-index procedure
Secondary Safety Endpoint: Freedom From Composite Adverse Events
Time frame: 30-days and 12-, 24-, and 36-months post-index procedure
Number of Stents Deployed With Acute Technical Success
Time frame: Intra-procedure
Number of Acute Lesion Success
Time frame: Intra-procedure
Number of Procedures With Acute Success
Time frame: Intra-procedure
Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure
Time frame: 24- and 36-months post-index procedure
Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure
Time frame: 30 days, 12-, 24-, and 36-months post-index procedure
Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure
Time frame: 30-days and 12-, 24-, and 36-months post-index procedure
Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure
Time frame: 24- and 36-months post-index procedure
Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure
Time frame: 12, 24, and 36 months Post-Index Procedure
Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
Time frame: 12, 24, and 36 Months Post-Index Procedure
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Time frame: 30-days, and 12-, 24-, and 36-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 19 Nov 2019.
- 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.
Jeffrey P Carpenter, MD principal investigator
Cooper Norcross Health
Mark D Mewissen, MD principal investigator
Wake Forest University Health Sciences
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTA followed by placement of LifeStent® Vascular Stent in people with Superficial Femoral Artery Stenosis, run by C. R. Bard at 29 sites in United States.
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: stopped early, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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 6 Nov 2019). 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?
Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure. (time frame: 30-days and 12-months). 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 19 Nov 2019.