A Prospective, Multicenter, Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries (LEVANT China)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Femoral Artery Stenosis
- Sponsor
- C. R. Bard
- Enrollment
- 148
- Locations
- 14
- Primary Endpoint
- Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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. .
Investigators
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;
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year
Time Frame: 0-12 months
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).
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
Time Frame: 0-30 days
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
Secondary Outcomes
- Procedural Success(1 month)
- Device Success(1 month)
- Technical Success(1 month)
- Acute Technical Success(1 month)
- Percentage of Subjects with Primary Patency of the Target Lesion(24 months)
- Target Lesion Revascularization(24 months)
- Change in Rutherford Classification(24 months)
- Change in Ankle Brachial Index(24 months)
- Percentage of subjects who died from any cause(24 months)
- Amputation-free Survival(24 months)
- Percentage of subjects with Target Vessel Revascularization(24 months)