Status:
COMPLETED
Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
Lead Sponsor:
C. R. Bard
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatmen...
Detailed Description
The study will observe subjects presenting with claudication or ischemic rest pain (Rutherford category 2-4) and long (10-24 cm in length) native lesions in the infra-inguinal segment (superficial fem...
Eligibility Criteria
Inclusion
- Subjects will be included if all of the following inclusion criteria apply:
- Age ≥18 years;
- The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);
- Rutherford Category 2-4;
- Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of ≥50% stenosis or occlusion (by visual estimate) and is amenable to treatment with LifeStent® and Lutonix DCB;
- Patients must be able to be treated with Lutonix DCB and LifeStent®;
- Total Lutonix DCB treated segment(s) of 10-24 cm in length;
- Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
- At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with LifeStent®).
- No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
- Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
- Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the tibioperoneal trunk.
Exclusion
- Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- Contraindication to Lutonix DCB or LifeStent® per current IFU;
- Life expectancy of \<1 year;
- Inability to take required antiplatelet/anticoagulant medications per the LifeStent® and Lutonix DCB IFU, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;
- Intended treatment of outflow disease during the index procedure;
- Intended use of laser, atherectomy or cryoplasty during index procedure;
- Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
- History of stroke within 3 months;
- History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
- Participation in an investigational drug or another investigational device study until this study's (Lutonix LifeStent® Study) primary endpoint is reached or previous enrollment in this study;
- Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the CIP or confound data interpretation;
- Target vessel and/or lesion involves a previously placed stent.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 2 2018
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT02278991
Start Date
October 1 2014
End Date
October 2 2018
Last Update
October 9 2019
Active Locations (12)
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1
Klinikum Arnsberg
Arnsberg, Germany, 59755
2
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, Germany, 29549
3
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany, 79189
4
Angiologikum Hamburg
Hamburg, Germany, 22527