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

Femoral Artery Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720003
• Other study ID #: BC1401PV
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 2020

Study information

• Verified date: January 2021
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: August 2020
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Constriction, Pathologic
• Femoral Artery Occlusion
• Femoral Artery Stenosis
• Occlusion of Popliteal Arteries
• Stenosis of Popliteal Arteries

Intervention

Device:
• LTX DCB
Treatment with a drug-coated balloon

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital. CMU	Beijing	Beijing
China	Chinese- PLA General Hospital	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	RENJI Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	General Hospital of Tianjin Medical University	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Device Success		1 month
Secondary	Technical Success		1 month
Secondary	Acute Technical Success		1 month
Secondary	Procedural Success		1 month
Secondary	Percentage of Subjects with Primary Patency of the Target Lesion		24 months
Secondary	Target Lesion Revascularization	Proportion of subjects with target lesion revascularization through 24 months	24 months
Secondary	Change in Rutherford Classification	Mean change in Rutherford Classification from baseline through 24 months	24 months
Secondary	Change in Ankle Brachial Index	Mean change in ankle brachial index from baseline through 24 months	24 months
Secondary	Percentage of subjects who died from any cause		24 months
Secondary	Amputation-free Survival	Percentage of subjects with above-the-ankle amputation-free survival	24 months
Secondary	Percentage of subjects with Target Vessel Revascularization		24 months