Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
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|ClinicalTrials.gov Identifier: NCT02278991|
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment|
|Peripheral Artery Disease||Device: Lutonix Drug Coated Balloon|
|Study Type :||Observational|
|Actual Enrollment :||149 participants|
|Official Title:||A Prospective, Multicenter, Single-Arm, Post-Market Study Using the Lutonix Drug Coated Balloon for Post-Dilatation of the Bard LifeStent Vascular Stent for Treatment of Long Lesions in Femoropopliteal Arteries|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||October 2, 2018|
Lutonix Drug Coated Balloon
Paclitaxel coated balloon catheter
Device: Lutonix Drug Coated Balloon
Subject will receive treatment with the Lutonix Drug Coated Balloon
- Primary patency at 12 months. [ Time Frame: 12 months ]Primary patency is defined as the absence of target lesion restenosis and freedom from target lesion revascularization.
- Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days. [ Time Frame: 30 days ]Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
- Procedural success [ Time Frame: Immediately after Intervention ]Defined as attainment of ≤30% residual stenosis by quantitative angiography immediately after intervention in the absence of peri-procedural complications.
- Technical success [ Time Frame: Immediately after intervention ]Defined as attainment of ≤30% residual stenosis by quantitative angiography.
- Device success [ Time Frame: Immediately after intervention ]Defined as successful delivery of the DCB to the target lesion and performance when used according to the clinical investigational plan.
- Freedom from Target Lesion Revascularization after 30 days, and 6, 12 and 24 months post-index procedure. [ Time Frame: 30 days, 6, 12 and 24 months ]Absence of Target Lesion Revascularization.
- Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure. [ Time Frame: 30 days, 6, 12 and 24 months ]Absence of Target Vessel Revascularization.
- Change in resting ankle brachial index (ABI) from baseline to 30 days, and 6, 12 and 24 months post-index procedure [ Time Frame: 30 days, 6, 12 and 24 months ]The ABI values will be recorded and compared to the baseline values. The ABI is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. A ratio of 0.9-1.3 is in the normal range. Lower ratios indicate bad blood perfusion of the leg.
- Change in Rutherford Classification from baseline to 30 days, and 6, 12 and 24 months post-index procedure [ Time Frame: 30 days, 6, 12 and 24 months ]Patients are enrolled with a Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).
- All-cause death [ Time Frame: 30 days, 6, 12 and 24 months ]Death by any cause will be counted.
- Amputation (above the ankle)-free survival [ Time Frame: 30 days, 6, 12 and 24 months ]Amputations above the ankle of the target leg will be counted.
- Target limb reintervention for treatment of thrombosis of target vessel or embolization to its distal vasculature [ Time Frame: 30 days, 6, 12 and 24 months ]Thrombosis in the target vessel and embolizations below the target lesion will be analazed separately from other stenoses.
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): NCT02278991
|Arnsberg, Germany, 59755|
|Herz- und Gefäßzentrum Bad Bevensen|
|Bad Bevensen, Germany, 29549|
|Universitäts-Herzzentrum Freiburg Bad Krozingen|
|Bad Krozingen, Germany, 79189|
|Hamburg, Germany, 22527|
|Immenstadt, Germany, 87509|
|Kassel, Germany, 34125|
|UKSH - Campus Lübeck|
|Lübeck, Germany, 23538|
|RoMed Klinikum Rosenheim|
|Rosenheim, Germany, 83022|
|Sonneberg, Germany, 96515|
|Weiden, Germany, 92637|
|University General Hospital of Patras|
|Patras, Greece, 26504|
|Sanok, Poland, 38-500|
|Principal Investigator:||Thomas Zeller, Prof.|