NCT02464501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

4.3 years

First QC Date

June 1, 2015

Last Update Submit

November 7, 2019

Conditions

Peripheral Arterial DiseaseCardiovascular DiseasePeripheral Vascular Disease

Keywords

PADCOPPER-APeripheral Arterial DiseaseOPCOcclusion Perfusion CatheterPaclitaxelPressanaPrecision Delivery System

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    1 month

Secondary Outcomes (11)

  • Primary Patency

    6 months

  • Primary Patency

    12 months

  • Improvement in Rutherford category

    3, 6, and 12 months

  • Primary Assisted Patency

    1, 3, 6, and 12 months

  • Secondary Patency

    1, 3, 6, and 12 months

  • +6 more secondary outcomes

Study Arms (1)

OPC Treatment

EXPERIMENTAL

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.

Other: Paclitaxel administration using the OPC

Interventions

Paclitaxel administration using the OPCOTHER
OPC Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Cardiology Associates

Fairhope, Alabama, 36532, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Coastal Vascular and Interventional

Pensacola, Florida, 32504, United States

Location

Vascular Institute of the Midwest

Davenport, Iowa, 52807, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70361, United States

Location

Michigan Outpatient Vascular Institute

Dearborn, Michigan, 48124, United States

Location

St. John Hospital

Detroit, Michigan, 48236, United States

Location

Mid-Michigan Heart & Vascular Center

Saginaw, Michigan, 48604, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Novant Health

Charlotte, North Carolina, 28204, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University Surgical Associates

Chattanooga, Tennessee, 37403, United States

Location

Kore Cardiovascular Research

Jackson, Tennessee, 38305, United States

Location

Huntsville Memorial Hospital

Huntsville, Texas, 77340, United States

Location

North Dallas Research Associates

McKinney, Texas, 75069, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

Tyler Cardiovascular Consultants

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseCardiovascular DiseasesPeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Frank Bunch, MD, FACC

    Cardiology Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 8, 2015

Study Start

May 20, 2015

Primary Completion

September 1, 2019

Study Completion

November 1, 2019

Last Updated

November 8, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(17)