The purpose of this study is to assess the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention of restenosis in infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis.
The purpose of this study is to assess the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention of restenosis in infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis. Subjects will be treated with the endovascular intervention selected by the treating physician in SFA reference vessels ranging from 4mm to 7mm in diameter and infrapopliteal vessels ranging from 2mm to 4mm. Following the achievement of optimal interventional results (less than thirty (30) percent residual stenosis without stenting) the OPC will be placed at the interventional treatment area and paclitaxel will be delivered to the treated segment. Data will be collected to assess acute safety, long-term safety and durability to demonstrate the safety and efficacy of paclitaxel delivered with the ACT, Inc. OPC device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Cardiology Associates
Fairhope, Alabama, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Primary Patency
Femoropopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by Peak Systolic Velocity Ratio (PSVR) ≤ 2.5 and clinically free from Target Lesion Revascularization.
Time frame: 12 months
Primary Patency
Infrapopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by freedom from target lesion occlusion and clinically free from Target Lesion Revascularization.
Time frame: 6 months
Freedom from major adverse events (MAEs)
MAEs are defined as target limb related death, major amputation in the target limb (amputation above the metatarsals), or target lesion revascularization (TLR) within one (1) month.
Time frame: 1 month
Primary Patency
Femoropopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by Peak Systolic Velocity Ratio (PSVR) ≤ 2.5 and clinically free from Target Lesion Revascularization.
Time frame: 6 months
Primary Patency
Infrapopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by freedom from target lesion occlusion and clinically free from Target Lesion Revascularization.
Time frame: 12 months
Improvement in Rutherford category
Time frame: 3, 6, and 12 months
Primary Assisted Patency
Patency of the target lesion following endovascular re-intervention of the target lesion due to symptomatic restenosis.
Time frame: 1, 3, 6, and 12 months
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Coastal Vascular and Interventional
Pensacola, Florida, United States
Vascular Institute of the Midwest
Davenport, Iowa, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Michigan Outpatient Vascular Institute
Dearborn, Michigan, United States
St. John Hospital
Detroit, Michigan, United States
Mid-Michigan Heart & Vascular Center
Saginaw, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Novant Health
Charlotte, North Carolina, United States
...and 7 more locations
Secondary Patency
Measured by patency of the target lesion after treatment of a (re)occlusion of the index lesion during the follow-up period.
Time frame: 1, 3, 6, and 12 months
Freedom from target lesion revascularization (TLR)
Time frame: 1, 3, 6, and 12 months
Freedom from target vessel revascularization (TVR)
Time frame: 1, 3, 6, and 12 months
Improvement in Walking Impairment Questionnaire scores
Time frame: 6 and 12 months
Device Success
Defined as the ability to deliver paclitaxel to the interventional treatment length as intended.
Time frame: Day 1 - Index Procedure
Freedom from major adverse events (MAEs)
Time frame: 1, 3, 6, and 12 months
Anticipated adverse events
Time frame: 1, 3, 6, and 12 months