The OPC for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee

Not Applicable

Completed

• Conditions: Peripheral Vascular Disease; Peripheral Arterial Disease; Cardiovascular Disease
• Interventions: Other: Paclitaxel administration using the OPC

• Registration Number: NCT02464501
• Lead Sponsor: Horizons International Peripheral Group

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-05-20
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Primary Completion: 2019-09
• Status Verified: 2019-11
• Study Completion: 2019-11
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Willing and able to provide informed consent and comply with all study requirements;

• Candidate for peripheral vascular femoropopliteal or infrapopliteal percutaneous intervention;

• Must be ≥ 18 years of age;

• Rutherford category 2, 3, 4, or 5;

• Willing and able to tolerate dual anti-platelet therapy (DAPT) for a minimum of one (1) month;

• Lab work within acceptable limits according to standard of care;

• INR < 2.0 if on warfarin or not on warfarin;

• Minimum sheath size used for the interventional procedure

  • 7x8 OPC Catheter - 7FR.
  • 3x15 OPC, 3x15 PRESSANA(TM), or 3x8 PRESSANA(TM) - 6FR.

General

Exclusion Criteria

• Life expectancy < three (3) years;
• Planned amputation prior to procedure;
• Pregnancy or nursing (a pregnancy test is required for all women of childbearing capabilities ≤ 7 days prior to the index procedure);
• Previous intervention of the target lesion with a drug eluting balloon or drug delivery catheter;
• Any treatment in the target vessel with drug eluting balloon;
• Acute limb ischemia
• Known allergy to paclitaxel;
• Known hypersensitivity to other drugs manufactured in Cremophor® EL (polyoxyethylated castor oil; e.g. Drugs containing polyoxyethylated castor oil are drugs such as miconazole, cyclosporine injection, nelfinavir mesylate, saperconazole, tacrolimus, and xenaderm ointment);
• Known allergy to anticoagulants;
• Known TRUE acetylsalicylic acid (ASA) allergy;
• Use of glycoprotein (GP) IIb/IIIa inhibitors during the procedure visit within 30 days following the index procedure;
• Target lesion treated with a cryoplasty balloon at the time of the index procedure;
• Hemorrhagic stroke within six (6) months;
• Renal failure or chronic kidney disease with GFR ≤30 mL/min or MDRD GFR ≤30 mL/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
• Prior vascular surgery of the index limb;
• Current enrollment in another investigational device or drug study;
• After obtaining informed consent, at any point up to introduction of the OPC, the investigator determines the study subject is not appropriate for the study.

Angiographic Inclusion Criteria:

• Reference vessel diameter (RVD) ≥ 4 mm and ≤ 7 mm for femoropopliteal arteries or ≥ 2 mm and ≤ 4 mm for infrapopliteal arteries;
• Either single or multiple lesions in the SFA and/or popliteal artery or single or multiple lesions in the infrapopliteal arteries (AT, PT, peroneal);
• For single lesion treatment, minimum lesion length ≥ 20 mm;
• Minimum of one patent infrapopliteal vessel;
• Pre-intervention percent DS ≥ 70%.

Angiographic Exclusion Criteria:

• Flow limiting dissection necessitating stent placement prior to OPC use;
• Post PTA residual stenosis ≥ 30% as visualized by treating physician;
• Perforation requiring a covered stent;
• For femoropopliteal target lesion or occlusion location extends distally beyond the P2 region of the popliteal artery or infrapopliteal lesion or occlusion location is at or proximal to the origin of the trifurcation vessel or below the ankle (top of the talus bone);
• Target lesion within a fractured stent;
• Target lesion within a stent and restenosed two (2) or more times;
• Significant (≥ 50% DS) inflow lesion or occlusion left untreated in the ipsilateral Iliac, SFA, or popliteal artery proximal to the target lesion;
• A lesion treated distal to the target lesion results in compromising inline flow distal to the target lesion;
• Visible thrombus in the target artery or proximal to the target artery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OPC Treatment	Paclitaxel administration using the OPC	Paclitaxel administration using the OPC for the prevention of restenosis in infrainguinal de novo and restenotic femoropopliteal lesions. Subjects will be treated with the endovascular intervention selected by the treating physician in reference vessels ranging from 4mm to 7mm in diameter. 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.

Primary Outcome Measures

Name	Time	Method
Primary Patency	6 months	Infrapopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by freedom from target lesion occlusion and clinically free from Target Lesion Revascularization.
Freedom from major adverse events (MAEs)	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Primary Patency	12 months	Infrapopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by freedom from target lesion occlusion and clinically free from Target Lesion Revascularization.
Improvement in Rutherford category	3, 6, and 12 months
Primary Assisted Patency	1, 3, 6, and 12 months	Patency of the target lesion following endovascular re-intervention of the target lesion due to symptomatic restenosis.
Secondary Patency	1, 3, 6, and 12 months	Measured by patency of the target lesion after treatment of a (re)occlusion of the index lesion during the follow-up period.
Freedom from target lesion revascularization (TLR)	1, 3, 6, and 12 months
Freedom from target vessel revascularization (TVR)	1, 3, 6, and 12 months
Improvement in Walking Impairment Questionnaire scores	6 and 12 months
Device Success	Day 1 - Index Procedure	Defined as the ability to deliver paclitaxel to the interventional treatment length as intended.
Freedom from major adverse events (MAEs)	1, 3, 6, and 12 months
Anticipated adverse events	1, 3, 6, and 12 months

Trial Locations

Locations (17)

Cardiology Associates; 🇺🇸 Fairhope, Alabama, United States

First Coast Cardiovascular Institute; 🇺🇸 Jacksonville, Florida, United States

Coastal Vascular and Interventional; 🇺🇸 Pensacola, Florida, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

Michigan Outpatient Vascular Institute; 🇺🇸 Dearborn, 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

Huntsville Memorial Hospital; 🇺🇸 Huntsville, Texas, United States

University Surgical Associates; 🇺🇸 Chattanooga, Tennessee, United States

Kore Cardiovascular Research; 🇺🇸 Jackson, Tennessee, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Cardiovascular Associates of East Texas; 🇺🇸 Tyler, Texas, United States

Tyler Cardiovascular Consultants; 🇺🇸 Tyler, Texas, United States

North Dallas Research Associates; 🇺🇸 McKinney, Texas, United States

St. John Hospital; 🇺🇸 Detroit, Michigan, United States

Vascular Institute of the Midwest; 🇺🇸 Davenport, Iowa, United States