- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01920308
A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY) (REALITY)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bad Krozingen, Germany, 79187
- University Heart Centre Bad Krozingen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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). |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Safety defined as freedom from death (after 30 days)
Time Frame: Through 12 months post procedure
|
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.
|
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
|
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.
|
Through 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Zeller, Prof. Dr., University Heart Centre in Bad Krozingen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BPV-13-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Artery Disease
-
Janssen Scientific Affairs, LLCHCA Research Institute, LLCRecruitingCoronary Artery Disease (CAD) | Peripheral Artery Disease (PAD)United States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedStructural Heart Disease | Obstructive Coronary Artery Disease | Obstructive Peripheral Artery DiseaseUnited States
-
Michael Lichtenberg, MDCompletedPeripheral Artery Disease (PAD)Germany
-
Helsinki University Central HospitalCompletedPeripheral Artery Occlusive Disease | Peripheral Artery Stenosis | Peripheral Artery RestenosisFinland
-
Fangge DengRecruitingPeripheral Artery Disease (PAD)China
-
Fundacion para la Formacion e Investigacion Sanitarias...Not yet recruiting
-
Rontis Hellas SAPharmassist LtdActive, not recruitingPeripheral Artery Disease (PAD)Greece
-
Boston Scientific CorporationCompletedAtherosclerosis | Peripheral Artery Disease | Plaque, Atherosclerotic | Artery Diseases, Peripheral | Occlusive Arterial DiseaseUnited States, Belgium, Canada, Japan, Austria, New Zealand
-
Seung-Whan Lee, M.D., Ph.D.Active, not recruitingCatheterization, Peripheral | Popliteal Artery | Angioplasty, Balloon | Femoral ArteryKorea, Republic of
-
Dartmouth-Hitchcock Medical CenterSociety for Vascular SurgeryCompletedPeripheral Artery Disease (PAD)United States
Clinical Trials on 5 mm Bard LifeStent Vascular Stent
-
C. R. BardMedicon, Inc.Completed
-
C. R. BardCompletedPeripheral Arterial Disease | Intermittent ClaudicationGermany
-
C. R. BardCompleted
-
W.L.Gore & AssociatesCompleted
-
C. R. BardTerminatedSuperficial Femoral Artery StenosisUnited States
-
Medical University of ViennaUnknownStent Restenosis | Intimal HyperplasiaAustria
-
C. R. BardCompletedPeripheral Artery DiseaseGermany
-
Instituto Nacional de Cardiologia Ignacio ChavezTerminatedCoronary Artery Disease (CAD) | Percutaneous Coronary Intervention (PCI) | High Bleeding RiskMexico
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7 | Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7 | Stage IVA Oropharyngeal Squamous... and other conditionsUnited States, Puerto Rico, South Africa
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityTerminatedPrimary Myelofibrosis | Anemia | Recurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Anatomic Stage IV Breast Cancer AJCC v8 | Recurrent Acute Myeloid Leukemia | Recurrent Myelodysplastic Syndrome | Refractory Acute Myeloid Leukemia | Refractory Chronic Myelomonocytic Leukemia | Refractory Myelodysplastic... and other conditionsUnited States