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LEVANT 2 Safety Registry

A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry)

NCT01790243•C. R. Bard

View on ClinicalTrials.gov

Summary

The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or non-pregnant female ≥18 years of age;
•2. Rutherford Clinical Category 2-4;
•3. Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;
•4. Length ≤15 cm;
•5. Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of \<15 cm);
•6. ≥70% stenosis by visual estimate;
•7. 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 TP trunk;
•8. De novo lesion(s) or non-stented restenotic lesion(s) \>90 days from prior angioplasty procedure;
•9. Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
•10. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
+5 more criteria

Exclusion Criteria

•Patients will be excluded if ANY of the following conditions apply:
•1. Pregnant or planning on becoming pregnant or men intending to father children;
•2. Life expectancy of \<5 years;
•3. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
•4. History of hemorrhagic stroke within 3 months;
•5. Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
•6. History of MI, thrombolysis or angina within 2 weeks of enrollment;
•7. Rutherford Class 0, 1, 5 or 6;
•8. Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
•9. Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
+9 more criteria

Locations (8)

Mission Cardiovascular Research Institute

Fremont, California, United States

Metro Health Hospital

Wyoming, Michigan, United States

Jackson Heart Clinic/St. Dominic's Hospital

Jackson, Mississippi, United States

Mercy Hospital

Springfield, Missouri, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

New York Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

TriHealth Heart Institute

Cincinnati, Ohio, United States

Mission Research Institute

New Braunfels, Texas, United States

Key Dates

Start Date

July 20, 2011

Primary Completion Date

November 27, 2015

Completion Date

November 1, 2018

Last Updated

June 5, 2020

Enrollment

1,189

ACTUAL participants

Conditions

Peripheral Artery DiseaseFemoropopliteal Artery OcclusionFemoropopliteal Stenosis

Interventions

Lutonix Drug Coated Balloon

DEVICE

Standard PTA Balloon

DEVICE

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

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RECRUITING

Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease

NCT07283289

Peripheral Artery Disease

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RECRUITING

Vascular Lab Resource (VLR) Biorepository

NCT05628948

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

LEVANT 2 Safety Registry

Inclusion Criteria

Exclusion Criteria

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease

Vascular Lab Resource (VLR) Biorepository

The COCOA-PAD II Trial

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)