Clinical trial NCT02278991: Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital Patients

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 treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery.

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 femoral artery \[SFA\] and/or proximal popliteal artery) who are candidates for stenting and pre-/post-dilatation with Drug Coated Balloon (DCB).

Eligibility criteria: Inclusion Criteria: Subjects will be included if all of the following inclusion criteria apply:

1. Age ≥18 years;
2. 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);
3. Rutherford Category 2-4;
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;
5. Patients must be able to be treated with Lutonix DCB and LifeStent®;
6. Total Lutonix DCB treated segment(s) of 10-24 cm in length;
7. Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
8. 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®).
9. 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;
10. Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
11. 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 Criteria:

1. Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
2. Contraindication to Lutonix DCB or LifeStent® per current IFU;
3. Life expectancy of \<1 year;
4. 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;
5. Intended treatment of outflow disease during the index procedure;
6. Intended use of laser, atherectomy or cryoplasty during index procedure;
7. Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
8. History of stroke within 3 months;
9. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
10. 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;
11. Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the CIP or confound data interpretation;
12. Target vessel and/or lesion involves a previously placed stent.

Primary outcomes:
measure: Primary patency at 12 months.
timeFrame: 12 months
measure: Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
timeFrame: 30 days
Secondary outcomes:
measure: Procedural success
timeFrame: Immediately after Intervention
measure: Technical success
timeFrame: Immediately after intervention
measure: Device success
timeFrame: Immediately after intervention
measure: Freedom from Target Lesion Revascularization after 30 days, and 6, 12 and 24 months post-index procedure.
timeFrame: 30 days, 6, 12 and 24 months
measure: Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure.
timeFrame: 30 days, 6, 12 and 24 months
measure: Change in resting ankle brachial index (ABI) from baseline to 30 days, and 6, 12 and 24 months post-index procedure
timeFrame: 30 days, 6, 12 and 24 months
measure: Change in Rutherford Classification from baseline to 30 days, and 6, 12 and 24 months post-index procedure
timeFrame: 30 days, 6, 12 and 24 months
measure: All-cause death
timeFrame: 30 days, 6, 12 and 24 months
measure: Amputation (above the ankle)-free survival
timeFrame: 30 days, 6, 12 and 24 months
measure: Target limb reintervention for treatment of thrombosis of target vessel or embolization to its distal vasculature
timeFrame: 30 days, 6, 12 and 24 months
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg
city: Bad Bevensen
country: Germany
facility: Herz- und Gefäßzentrum Bad Bevensen
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen
city: Hamburg
country: Germany
facility: Angiologikum Hamburg
city: Immenstadt
country: Germany
facility: Klinik Immenstadt
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Lübeck
country: Germany
facility: UKSH - Campus Lübeck
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Sonneberg
country: Germany
facility: Gefäßzentrum Sonneberg
city: Weiden
country: Germany
facility: Klinikum Weiden
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Sanok
country: Poland
facility: SPZOZ Sanok
Study officials:
name: Thomas Zeller, Prof.
role: PRINCIPAL_INVESTIGATOR
References: