A Prospective, Multicenter, Single-Arm Trial With the Lutonix Drug Coated Balloon for Treatment of Long Lesions in Femoropopliteal Arteries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Femoral Artery Occlusion
- Sponsor
- C. R. Bard
- Enrollment
- 125
- Locations
- 14
- Primary Endpoint
- Overall Medical Safety
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
Detailed Description
The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and TASC II Class C or D lesions ≥14 cm in length in the native femoropopliteal artery. After successful pre-dilatation (1mm \< RVD) and spot stenting (if necessary, with length minimized to mechanical defect), subjects will receive treatment with the Lutonix Drug Coated Balloon (DCB). The primary safety and efficacy endpoint assessments are performed at 12 months. Clinical follow-up continues through a minimum of 2 years and telephone follow-up through a minimum of 3 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical Criteria
- •≥ 18 years of age;
- •Rutherford Clinical Category 2-4;
- •The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF).
- •Angiographic Criteria
- •Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery (by visual estimate) that is amenable to DCB with or without stenting;
- •TASC II Class C or D Lesions with intended target lesion treatment segment(s) cumulatively ≥14 cm in length;
- •de novo lesion(s) or non-stented restenotic lesion(s) \> 90 days from prior angioplasty procedure;
- •Proximal margin of target lesion(s) starts ≥ 1 cm below the common femoral bifurcation;
- •Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk;
Exclusion Criteria
- •Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- •Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU)
- •Life expectancy of \< 1year;
- •Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in an investigational device or pharmaceutical clinical trial during the follow up period is not allowed.
- •History of stroke within 3 months;
- •History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
- •Prior vascular surgery of the index limb, with the exception of endarterectomy or remote common femoral patch angioplasty, separated by at least 1 cm from the target lesion;
- •Target lesion involves a previously placed stent
- •Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
- •No normal proximal artery segment in which duplex flow velocity can be measured;
Outcomes
Primary Outcomes
Overall Medical Safety
Time Frame: 12 Months
Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle) and index limb re-intervention. Success is freedom from all specified events; failure is one or more specified events occurs.
Primary Endpoint Efficacy, measured by presence of primary patency of the target lesion. Patency is assessed by a Corelab based on ultrasound images
Time Frame: 12 Months
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis. Binary restenosis is adjudicated by the independent, blinded core laboratory based on threshold Doppler PSVR ≥ 2.5 (together with wafeform analysis \& color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol). Clinically-Driven TLR is adjudicated by the Clincal Events Committee.
Secondary Outcomes
- Secondary Endpoint Efficacy: Acute Device Success(During index procedure)
- Secondary Endpoint Efficacy: Technical Success(During index procedure)
- Secondary Endpoint Efficacy: Procedural Success(Until index hospitalization discharge)
- Secondary Endpoint Efficacy: Primary Patency(6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Efficacy: Secondary Patency(6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Efficacy: Clinically-driven Target Lesion Revascularization (TLR)(6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Efficacy: Target Lesion Revascularization (TLR)(6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Efficacy: Change of Rutherford classification from baseline(6, 12, 24 months after index procedure)
- Secondary Endpoint Efficacy: Change of resting Ankle Brachial Index (ABI) from baseline(6, 12, 24 months after index procedure)
- Secondary Endpoint Efficacy: Change in Walking Impairment Questionnaire from baseline(6, 12, 24 months after index procedure)
- Secondary Endpoint Efficacy: Change in quality of life from baseline, as measured by EQ-5D(6, 12, 24 months after index procedure)
- Secondary Endpoint Medical Safety: Major vascular complications(≤30 days after index procedure)
- Secondary Endpoint Medical Safety: Composite Safety(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: All-cause death(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: Major amputation at target limb(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: Minor amputation at target limb(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: Target Vessel Revascularization (TVR)(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: Target Limb Reintervention(1, 6, 12, 24, 36 months after index procedure)