Clinical trial NCT02720003: A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries
Official title: A Prospective, Multicenter, Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries (LEVANT China)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Artery Stenosis
Femoral Artery Occlusion
Stenosis of Popliteal Arteries
Occlusion of Popliteal Arteries
Keywords: Atherosclerosis
Superficial Femoral Artery
Proximal Popliteal Artery
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 criteria: 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;
* 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.

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;
* 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;
* Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, embolic protection device, etc.).

Primary outcomes:
measure: Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year
timeFrame: 0-12 months
measure: 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
timeFrame: 0-30 days
Secondary outcomes:
measure: Device Success
timeFrame: 1 month
measure: Technical Success
timeFrame: 1 month
measure: Acute Technical Success
timeFrame: 1 month
measure: Procedural Success
timeFrame: 1 month
measure: Percentage of Subjects with Primary Patency of the Target Lesion
timeFrame: 24 months
measure: Target Lesion Revascularization
timeFrame: 24 months
measure: Change in Rutherford Classification
timeFrame: 24 months
measure: Change in Ankle Brachial Index
timeFrame: 24 months
measure: Percentage of subjects who died from any cause
timeFrame: 24 months
measure: Amputation-free Survival
timeFrame: 24 months
measure: Percentage of subjects with Target Vessel Revascularization
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital. CMU
state: Beijing
city: Beijing
country: China
facility: Chinese- PLA General Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: RENJI Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
Study officials:
affiliation: Chinese PLA General Hospital
name: Wei Guo, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Weiguo Fu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Shijitan Hospital. CMU
name: Fuxian Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Tong Qiao
role: PRINCIPAL_INVESTIGATOR
affiliation: RenJi Hospital
name: Lan Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine
name: Xinwu Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Feng Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Fujian Medical University
name: Pingfan Guo
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Shaomang Lin
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Hebei Medical University
name: Wei Bi
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Jichun Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Qilu Hospital of Shandong University
name: Jianjun Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Haofu Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University General Hospital
name: Xiangchen Dai
role: PRINCIPAL_INVESTIGATOR
References: