Prevention of Restenosis Following Revascularization

This study has been terminated.
(Study was terminated due to changing sponsor priorities, and was not based on safety or outcomes data.)
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00518284
First received: August 16, 2007
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)


Condition Intervention Phase
Vascular Disease, Peripheral
Drug: Nanoparticle Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Trial of ABI-007 (Paclitaxel Albumin-bound Particles) for the Prevention of Restenosis Following Revascularization of the Superficial Femoral Artery (SFA)

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Target Vessel Revascularization at 9 Months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Target vessel revascularization (TVR) was defined as percutaneous revascularization or bypass of the target lesion or any segment of the artery containing the target lesion. The percentage of participants requiring revascularization of the target vessel was determined by stenosis of > 50% confirmed by angiography.


Secondary Outcome Measures:
  • Systolic Velocity Ratio (SVR) > 2.0 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound.

  • Change From Baseline in Walking Impairment Questionnaire (WIQ) Score [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient's walking ability. Scores range from 0 (no difficulty) to 100 (much difficulty).

  • Decrease in Ankle Brachial Index (ABI) > 0.15 [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]

    The percentage of participants with a decrease in the Ankle Brachial Index (ABI) > 0.15.

    Ankle Brachial Index = Systolic Ankle Pressure / Systolic Brachial Pressure.


  • Target Lesion Revascularization (TLR) at 9 Months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Target lesion revascularization (TLR) was defined as repeat percutaneous intervention or bypass surgery of the previously treated target lesion (or blockage). The percentage of participants requiring revascularization of the target lesion was determined by stenosis of > 50% confirmed by angiography.

  • Number of Deaths [ Time Frame: Up to 11 months ] [ Designated as safety issue: Yes ]
    Number of patients who died due to any cause.

  • Number of Participants With Myocardial Infarction (MI) [ Time Frame: Up to 11 months ] [ Designated as safety issue: Yes ]
    The number of patients experiencing Myocardial Infarction (MI) during the study. Myocardial Infarction was defined as new pathologic Q waves of at least 0.04 seconds, or an increase in serum creatine kinase to more than twice the normal code together with a pathologic increase in myocardial isoenzymes.

  • Number of Participants With a Stroke [ Time Frame: Up to 11 months ] [ Designated as safety issue: Yes ]
    The number of patients experiencing a stroke during the study. Stroke was defined as any sudden development of neurological deficits lasting more than 24 hours, and if a brain imaging study is performed it shows an infarction or hemorrhage. A transient ischemic attack is a neurological deficit lasting less than 24 hours and, if an imaging study is performed, shows no evidence of infarction or hemorrhage.

  • Minimum Lumen Diameter [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically.

  • Late Loss [ Time Frame: Day 1 (following revascularization) and 9 months ] [ Designated as safety issue: No ]
    Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm.

  • Percentage of Participants With Binary Restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography.

  • Diameter Stenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Diameter stenosis is calculated as [1 - (minimum lumen diameter (MLD) / reference vessel diameter)] * 100, where the reference vessel diameter is the vessel diameter measured in a healthy segment of the target vessel proximal as close as possible to the lesion.


Enrollment: 6
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Drug Treatment Control
Following revascularization, participants did not receive any study drug treatment.
Experimental: Proximal to Lesion + IV
Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
Drug: Nanoparticle Paclitaxel
Nanoparticle albumin-bound paclitaxel, 45 mg/m^2.
Other Names:
  • ABI-007
  • Abraxane®
  • Coroxane™
Experimental: During Flow Arrest
Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
Drug: Nanoparticle Paclitaxel
Nanoparticle albumin-bound paclitaxel, 45 mg/m^2.
Other Names:
  • ABI-007
  • Abraxane®
  • Coroxane™
Experimental: During Flow Arrest + IV
Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
Drug: Nanoparticle Paclitaxel
Nanoparticle albumin-bound paclitaxel, 45 mg/m^2.
Other Names:
  • ABI-007
  • Abraxane®
  • Coroxane™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant and non-lactating female and greater than or equal to 18 years of age. All females if child bearing potential must have a negative serum pregnancy test
  • Patient is determined to have peripheral artery disease (PAD) classified as Rutherford category 1-4 (grade I/II) - mild, moderate, or severe claudication or ischemic rest pain
  • Patient has de novo lesion causing occlusion or an angiographic stenosis of at least 50% in the superficial femoral artery
  • Patient has a single or multiple lesions located in the superficial femoral artery with a total length 5-15 cm.
  • Normal vessel diameter of the SFA is 4-6 mm
  • Patient must have a visibly patent (by angiography) popliteal artery below the target lesion
  • No residual flow limiting dissection or residual stenosis greater 30% (visual estimate) after percutaneous balloon angioplasty (PTA) or provisional stenting. Treatment with provisional stenting will be allowed only for flow-limiting dissection, grade C/D or greater than 30 % residual stenosis angiographically after angioplasty alone.
  • No target vessel thrombosis confirmed angiography post-PTA procedure
  • No distal embolization within target limb
  • Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to any premedication, prior to performance of revascularization procedures, and prior to participation in any study-related activities

Exclusion Criteria:

  • Women of child bearing potential who do not use adequate contraception
  • Patients who have experienced acute onset of claudication
  • History of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
  • Patients with lesions requiring treatment with atherectomy or primary stenting
  • Target lesion in which PTA failure would require treatment by provisional stenting with more than 2 stents
  • Patient has a life expectancy of less than 36 months or there are factors making clinical follow up difficult (no fixed address, etc)
  • Additional planned vascular procedure in treated extremity (note that concurrent endovascular treatment of iliac disease is allowable)
  • Patient is immunosuppressed or is HIV positive
  • Any individual who may refuse a blood transfusion
  • Documented major gastrointestinal bleeding within 3 months
  • The following lab values at baseline are exclusionary:
  • Serum creatinine greater or equal to 2.5 mg/dl
  • Platelet count less than 100,000 cells/mm^3
  • Uncorrectable coagulopathy with international normalized ratio (INR) greater than 2.0
  • Absolute Neutrophil Count (ANC) less than 2000 cells mm^3
  • Hemoglobin (Hgb) less than 9 g/dl
  • Total Bilirubin greater than 1.5 mg/dl
  • Alanine transaminase (SGPT) greater than 2.5 x upper limit normal range (ULN)
  • Aspartate transaminase (SGOT) greater than 2.5 x ULN
  • Alkaline phosphatase greater than 2.5 x ULN
  • Total cholesterol greater than 350 mg/dl or Low Density Lipoprotein greater than 200 mg/dl
  • Known allergies/hypersensitivity/contraindication to the study drug, to taxanes, to any required study treatment:aspirin, heparin, clopidogrel bisulfate, stent materials, or to ticlopidine, or dipyridamole
  • Patient treated with bivalirudin (Angiomax)
  • Pre-existing sensory neuropathy of National Cancer Institute (NCI) Toxicity Grade >1
  • Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial
  • Renal failure requiring hemodialysis
  • Lower extremity or pedal pulse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518284

Locations
United States, California
UC Davis Medical Center, Ellison Ambulatory Care Center Cardiology Suite 3400
Sacramento, California, United States, 95817
United States, Florida
Vascular & Interventional Physicians
Gainsville, Florida, United States, 32605
United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803
United States, Michigan
Michigan Vascular Research Center
Flint, Michigan, United States, 48507
United States, New Jersey
Holy Name Hospital
Teaneck, New Jersey, United States, 07666
United States, Ohio
Lindner Clinical Trials Center
Cincinnati, Ohio, United States, 45219
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: José Iglesias, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00518284     History of Changes
Other Study ID Numbers: CVR002
Study First Received: August 16, 2007
Results First Received: February 21, 2012
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Restenosis
Superficial Femoral Artery
Prevention of restenosis
Revascularization of the superficial Femoral Artery

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014