Prevention of Restenosis Following Revascularization

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00518284
• Date of registration: 16/08/2007
• Primary sponsor: Celgene Corporation
• Public title: Prevention of Restenosis Following Revascularization
• Scientific 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)
• Date of first enrolment: January 2008
• Target sample size: 6
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00518284
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: José Iglesias, MD
• Affiliation: Celgene Corporation

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Vascular Disease, Peripheral

Intervention(s)

Drug: Nanoparticle Paclitaxel

Primary Outcome(s)

Target Vessel Revascularization at 9 Months [Time Frame: 9 months]

Secondary Outcome(s)

Change From Baseline in Walking Impairment Questionnaire (WIQ) Score [Time Frame: Baseline and Month 9]

Decrease in Ankle Brachial Index (ABI) > 0.15 [Time Frame: Baseline and Month 9]

Diameter Stenosis [Time Frame: 9 months]

Late Loss [Time Frame: Day 1 (following revascularization) and 9 months]

Minimum Lumen Diameter [Time Frame: 9 months]

Number of Deaths [Time Frame: Up to 11 months]

Number of Participants With a Stroke [Time Frame: Up to 11 months]

Number of Participants With Myocardial Infarction (MI) [Time Frame: Up to 11 months]

Percentage of Participants With Binary Restenosis [Time Frame: 9 months]

Systolic Velocity Ratio (SVR) > 2.0 [Time Frame: 9 months]

Target Lesion Revascularization (TLR) at 9 Months [Time Frame: 9 months]

Secondary ID(s)

CVR002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors