A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY) (REALITY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01920308|
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : November 10, 2016
|Condition or disease||Intervention/treatment|
|Peripheral Artery Disease||Device: 5 mm Bard LifeStent Vascular Stent|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY)|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||July 2015|
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).
Device: 5 mm Bard LifeStent Vascular Stent
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.
- 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 ]
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920308
|University Heart Centre Bad Krozingen|
|Bad Krozingen, Germany, 79187|
|Principal Investigator:||Thomas Zeller, Prof. Dr.||University Heart Centre in Bad Krozingen|