NCT02720003

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2.6 years

First QC Date

February 26, 2016

Last Update Submit

January 19, 2021

Conditions

Femoral Artery StenosisFemoral Artery OcclusionStenosis of Popliteal ArteriesOcclusion of Popliteal Arteries

Keywords

AtherosclerosisSuperficial Femoral ArteryProximal Popliteal Artery

Outcome Measures

Primary Outcomes (2)

  • Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year

    Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio \[PSVR\] ≥2.5 and/or abnormal waveforms, as determined by an Independent Core Laboratory) and freedom from target lesion revascularization (TLR).

    0-12 months

  • Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death

    Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death

    0-30 days

Secondary Outcomes (11)

  • Device Success

    1 month

  • Technical Success

    1 month

  • Acute Technical Success

    1 month

  • Procedural Success

    1 month

  • Percentage of Subjects with Primary Patency of the Target Lesion

    24 months

  • +6 more secondary outcomes

Study Arms (1)

LTX DCB

EXPERIMENTAL

Patients treated with Bard Lutonix DCB

Device: LTX DCB

Interventions

LTX DCBDEVICE

Treatment with a drug-coated balloon

LTX DCB

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
  • A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow iliac and/or common femoral artery lesions);
  • No vascular interventions, surgical or interventional procedures within 2 weeks before and/or planned 30 days after the protocol treatment.

You may not qualify if:

  • 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;
  • The lesion is a post-DCB restenosis, or within or adjacent to an aneurysm; Ipsilateral retrograde access;
  • There is no normal proximal arterial segment in which duplex flow velocity can be measured;
  • Known inadequate distal outflow (≥50% stenosis of distal popliteal and/or all three tibial vessels;), or planned future treatment of vascular disease distal to the target lesion;
  • Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
  • Severe calcification that renders the lesion un-dilatable or failed pre-dilatation, defined by a residual stenosis \>50% or major flow limiting dissection;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Beijing Shijitan Hospital. CMU

Beijing, Beijing Municipality, 100038, China

Location

Chinese- PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

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

Nanjing, Jiangsu, 210008, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

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

Shanghai, Shanghai Municipality, 200011, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

RENJI Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

General Hospital of Tianjin Medical University

Tianjin, China

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Wei Guo, Professor

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

  • Weiguo Fu, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

  • Fuxian Zhang

    Beijing Shijitan Hospital. CMU

    PRINCIPAL INVESTIGATOR

  • Tong Qiao

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

  • Lan Zhang

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

  • Xinwu Lu

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

    PRINCIPAL INVESTIGATOR

  • Feng Wang

    The First Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

  • Pingfan Guo

    First Affiliated Hospital of Fujian Medical University

    PRINCIPAL INVESTIGATOR

  • Shaomang Lin

    Second Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

  • Wei Bi

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

  • Jichun Zhao

    West China Hospital

    PRINCIPAL INVESTIGATOR

  • Jianjun Jiang

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

  • Haofu Wang

    The Affiliated Hospital of Qingdao University

    PRINCIPAL INVESTIGATOR

  • Xiangchen Dai

    Tianjin Medical University General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 25, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2018

Study Completion

August 1, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

CN(14)