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Vascular Disease, PeripheralPhase 2NCT00518284

Prevention of Restenosis Following Revascularization

A Phase 2 study testing Nanoparticle Paclitaxel in people with Vascular Disease, Peripheral, run by Celgene Corporation at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Vascular Disease, Peripheral
What is being tested?
Nanoparticle Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
7 sitesUnited States
Study dates
Jan 2008to Sep 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Lindner Clinical Trials Center

    Cincinnati, Ohio, 45219

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52803

  • Michigan Vascular Research Center

    Flint, Michigan, 48507

  • Vascular & Interventional Physicians

    Gainsville, Florida, 32605

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • UC Davis Medical Center, Ellison Ambulatory Care Center Cardiology Suite 3400

    Sacramento, California, 95817

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

Other trials in United States

About this study

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)

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

Being tested
Nanoparticle Paclitaxel
Keywords
Restenosis, Superficial Femoral Artery, Prevention of restenosis, Revascularization of the superficial Femoral Artery
Medical subject headings
Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nanoparticle PaclitaxelDrug

    Also called ABI-007, Abraxane®, Coroxane™

    Nanoparticle albumin-bound paclitaxel, 45 mg/m^2.

Study groups in NCT00518284
Study groupRoleWhat they receive
No Drug Treatment ControlNo interventionFollowing revascularization, participants did not receive any study drug treatment.
Proximal to Lesion + IVExperimentalParticipants 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.
Receives: Drug: Nanoparticle Paclitaxel
During Flow ArrestExperimentalParticipants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
Receives: Drug: Nanoparticle Paclitaxel
During Flow Arrest + IVExperimentalParticipants 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.
Receives: Drug: Nanoparticle Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Vessel Revascularization at 9 Months

    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.

    Measured: 9 months

Secondary outcomes (11)

  1. Systolic Velocity Ratio (SVR) > 2.0

    The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound.

    Measured: 9 months

  2. Change From Baseline in Walking Impairment Questionnaire (WIQ) Score

    The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient's walking ability. Scores range from 0 (no difficulty) to 100 (much difficulty).

    Measured: Baseline and Month 9

  3. Decrease in Ankle Brachial Index (ABI) > 0.15

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

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

    Measured: Baseline and Month 9

  4. Target Lesion Revascularization (TLR) at 9 Months

    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.

    Measured: 9 months

  5. Number of Deaths

    Number of patients who died due to any cause.

    Measured: Up to 11 months

  6. Number of Participants With Myocardial Infarction (MI)

    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.

    Measured: Up to 11 months

  7. Number of Participants With a Stroke

    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.

    Measured: Up to 11 months

  8. Minimum Lumen Diameter

    Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically.

    Measured: 9 months

  9. Late Loss

    Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm.

    Measured: Day 1 (following revascularization) and 9 months

  10. Percentage of Participants With Binary Restenosis

    Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography.

    Measured: 9 months

  11. Diameter Stenosis

    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.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionAug 2009
  4. Study completionSep 2009

Why it stopped: Study was terminated due to changing sponsor priorities, and was not based on safety or outcomes data.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00518284
Sponsor's protocol ID
CVR002
Status last verified
Feb 2012
First submitted
16 Aug 2007
Last updated
13 Mar 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nanoparticle Paclitaxel in people with Vascular Disease, Peripheral, run by Celgene Corporation at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel Revascularization at 9 Months (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00518284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2012.

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