Overview

This trial is active, not recruiting.

Condition peripheral artery disease
Treatment lutonix drug coated balloon
Sponsor C. R. Bard
Start date October 2014
End date September 2017
Trial size 149 participants
Trial identifier NCT02278991, CL0022-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Paclitaxel coated balloon catheter
lutonix drug coated balloon
Subject will receive treatment with the Lutonix Drug Coated Balloon

Primary Outcomes

Measure
The primary efficacy endpoint is primary patency at 12 months. Primary patency is defined as the absence of target lesion restenosis and freedom from target lesion revascularization.
time frame: 12 months
The primary safety endpoint is freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
time frame: 30 days

Secondary Outcomes

Measure
Procedural success, defined as attainment of ≤30% residual stenosis by quantitative angiography (QA) immediately after intervention in the absence of peri-procedural complications.
time frame: Immediately after Intervention
Technical success, defined as attainment of ≤30% residual stenosis by QA.
time frame: Immediately after intervention
Device success, defined as successful delivery of device to target lesion and performance when used according to the clinical investigational plan.
time frame: Immediately after intervention
Freedom from TLR after 30 days, and 6, 12 and 24 months post-index procedure.
time frame: 30 days, 6, 12 and 24 months
Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure.
time frame: 30 days, 6, 12 and 24 months
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
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
All-cause death
time frame: 30 days, 6, 12 and 24 months
Amputation (above the ankle)-free survival
time frame: 30 days, 6, 12 and 24 months
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 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 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) Exclusion Criteria: 1. Life expectancy of <1 year 2. 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 3. Intended treatment of outflow disease during the index procedure 4. Intended use of laser, atherectomy or cryoplasty during index procedure 5. Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel 6. History of stroke within 3 months 7. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment

Additional Information

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
Principal investigator Thomas Zeller, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by C. R. Bard.