Clinical trial NCT00518284: Prevention of Restenosis Following Revascularization
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vascular Disease, Peripheral
Keywords: Restenosis
Superficial Femoral Artery
Prevention of restenosis
Revascularization of the superficial Femoral Artery
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: Target Vessel Revascularization at 9 Months
timeFrame: 9 months
Secondary outcomes:
measure: Systolic Velocity Ratio (SVR) > 2.0
timeFrame: 9 months
measure: Change From Baseline in Walking Impairment Questionnaire (WIQ) Score
timeFrame: Baseline and Month 9
measure: Decrease in Ankle Brachial Index (ABI) > 0.15
timeFrame: Baseline and Month 9
measure: Target Lesion Revascularization (TLR) at 9 Months
timeFrame: 9 months
measure: Number of Deaths
timeFrame: Up to 11 months
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: Up to 11 months
measure: Number of Participants With a Stroke
timeFrame: Up to 11 months
measure: Minimum Lumen Diameter
timeFrame: 9 months
measure: Late Loss
timeFrame: Day 1 (following revascularization) and 9 months
measure: Percentage of Participants With Binary Restenosis
timeFrame: 9 months
measure: Diameter Stenosis
timeFrame: 9 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center, Ellison Ambulatory Care Center Cardiology Suite 3400
state: California
city: Gainsville
country: United States
facility: Vascular & Interventional Physicians
state: Florida
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Flint
country: United States
facility: Michigan Vascular Research Center
state: Michigan
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Cincinnati
country: United States
facility: Lindner Clinical Trials Center
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Celgene Corporation
name: José Iglesias, MD
role: STUDY_DIRECTOR
References: