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COMPLETEDNA

A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries

A Prospective, Multicenter, Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries (LEVANT China)

NCT02720003•C. R. Bard

View on ClinicalTrials.gov

Summary

To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.

Detailed Description

The study will enroll patients presenting with claudication or ischemic rest pain due to stenotic lesions in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful pre-dilatation, subjects determined by the investigator not to require stenting based on defined angiographic criteria will receive the BARD LTX DCB. .

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female ≥18 and \< 85 years of age;
•Documented diagnosis of peripheral arterial disease (PAD) with Rutherford Classification stages 2-4;
•Patient is willing to provide informed consent and comply with the required - follow up visits, testing schedule and medication regimen;
•Angiographic Criteria
•Single lesion or up to two focal lesions (not separated by \>3 cm) (total vessel segment length ≤20 cm) in native superficial femoral and/or popliteal arteries;
•≥70% diameter stenosis by visual estimate;
•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;
•De novo lesion(s) or non-stented restenotic lesion(s) \>90 days from prior angioplasty procedure;
•Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
•Target vessel diameter between ≥4 and ≤7 mm and able to be treated with available device size matrix;
+3 more criteria

Exclusion Criteria

•Patients will be excluded if ANY of the following conditions apply:
•Breastfeeding or pregnant or planning on becoming pregnant or men intending to father children;
•Life expectancy of \< 2 year;
•Patient is currently participating in an investigational drug or other device study or previously enrolled in this study;
•History of stroke within 3 months;
•History of MI, thrombolysis or angina within 2 weeks of enrollment;
•Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis);
•Diagnosed active systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure
•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;
•Inability to take required study medications or allergy to paclitaxel or paclitaxel related compounds or contrast that cannot be adequately managed with pre- and post-procedure medication;
+6 more criteria

Locations (14)

Beijing Shijitan Hospital. CMU

Beijing, Beijing Municipality, China

Chinese- PLA General Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 1, 2016

Primary Completion Date

October 1, 2018

Completion Date

August 1, 2020

Last Updated

January 20, 2021

Enrollment

148

ACTUAL participants

Conditions

Femoral Artery StenosisFemoral Artery OcclusionStenosis of Popliteal ArteriesOcclusion of Popliteal Arteries

Interventions

LTX DCB

DEVICE

Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease

NCT07338890

Superficial Femoral Artery StenosisIliac Artery Stenosis+1 more

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COMPLETEDNA

CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery

NCT05734157

Femoral Artery StenosisPopliteal Artery Stenosis+2 more

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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: January 20, 2021Data 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

A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries

Inclusion Criteria

Exclusion Criteria

Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease

CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery

VFI in Healthy Vessels

Efficacy and Safety Comparison of the Open Surgical and Endovascular Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D.

Efficacy and Safety Comparison of the Endovascular and the Hybrid Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D

CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")