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Peripheral Arterial DiseasePhase 3NCT00111826

SIMPADICO - Study of Immune Modulation Therapy in Peripheral Arterial Disease and Intermittent Claudication Outcomes

A Phase 3 study testing Celacade™ system in people with Peripheral Arterial Disease and Arterial Occlusive Diseases, run by Vasogen.

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 assess the effects of the Celacade™ system in patients with intermittent claudication. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Celacade™ system
Type of treatment
Medical device
How many people
500 participants
Where
No sites listed yet
Study dates
Jan 2003to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

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

Who may be able to join

  • History of intermittent claudication (Fontaine stage II) due to peripheral arterial disease, which has been stable (both clinically and therapeutically) for 3 months prior to screening.
  • Resting ankle-brachial index (ABI) in at least one limb ≤ 0.85. For diabetics with falsely elevated ABI due to non-compressible tibial arteries, the toe brachial index (TBI) will be measured and has to be ≤ 0.7 at rest.
  • An absolute claudication distance (ACD) of≥ 50 meters confirmed on two consecutive visits at least one week apart. The change in ACD between the two consecutive assessments (i.e. Visit 0 and 1 or Visit 1 and 2) has to be within ± 20%.
  • Walking distance must be limited by IC, which will be confirmed by a ≥ 20% decrease in ABI in the worse claudicating limb immediately following the screening treadmill tests. The worse claudicating limb (or "index leg") will be defined either as (1) the most symptomatic leg or (2) the leg with the lowest resting ABI and documented prior to the first (pre-screening) treadmill test. Post-exercise and resting ABIs will be compared within the same leg at each screening treadmill test. This criterion will not apply to diabetics with non-compressible tibial arteries (i.e. only the resting TBI will be measured in these patients).
  • Age ≥40 years

Who cannot join

  • Women who are pregnant, lactating, or of childbearing potential not using accepted contraceptive methods, as assessed by the investigator.
  • Clinically relevant abnormal findings in the clinical history or physical examination at the screening assessment that would interfere with the objectives of the study or that would, in the investigator's opinion, preclude safe completion of the study. Abnormal findings could include: hepatitis, HIV infection, AIDS, other immune deficiency syndromes, serious active infections, gastrointestinal tract bleeding or any severe or acute concomitant illness or injury.
  • Critical limb ischemia (CLI) defined as ischemic rest pain, ulcerative lesions or gangrene [Rutherford-Becker Classification Grade II-III (corresponding to Fontaine stage III-IV)].
  • Previous endovascular or surgical revascularization within 6 months prior to study entry or anticipated during the first 6 months of the study.
  • Active inflammatory vascular disease (e.g. Buerger's disease).
  • Major peripheral neuropathies, including severe diabetic neuropathy to the extent that it may interfere with the evaluation of claudication.
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  • Any condition that limits walking ability, other than claudication (e.g. arthritis, angina, chronic obstructive pulmonary disease [COPD], etc.)
  • Malignancy within five years prior to screening. Basal cell carcinoma, provided that it is neither infiltrating nor sclerosing, and carcinoma in situ of the cervix are exemptions.
  • Organ transplant recipients.
  • Allergy to sodium citrate, or any "caine" type of local anesthetic.
  • Systemic corticosteroids, antineoplastics and immunosuppressive drug therapy (e.g. cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), DNA depleting or cytotoxic drugs taken within 4 weeks prior to study treatment.
  • Currently taking medications indicated for intermittent claudication (i.e. pentoxifylline or cilostazol). To be eligible, patient must not have taken these medications for at least 8 weeks prior to study enrollment.
  • Participation in another study involving an investigational or licensed drug or device in the 4 weeks preceding enrollment or during this study.
  • Previous Celacade™ treatment.
  • Any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, and a history of non-compliance).

About this study

Official title: Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of the Celacade™ System in Improving Walking Distance in Patients With Intermittent Claudication Secondary to Peripheral Arterial Disease

The purpose of this study is to assess the effects of the Celacade™ system in patients with intermittent claudication.

Read the detailed description

SIMPADICO was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 553 patients with claudication at 50 sites in Canada and the United States. The mean (±SD) patient age was 67±10 years; 72% were males. The duration of claudication was 6.0±6.1 years at entry; 91% had a history of smoking and 34% were current smokers; 36.5% had diabetes. Resting ABI was 0.59+0.14; baseline ICD was 132±104 and ACD 307±209 meters. Results showed that there was no increase in ACD or ICD at 26 weeks with immune modulation therapy (IMT using the Celacade™ system, Vasogen Inc.) compared to placebo and no measurable improvement in quality of life with IMT compared to placebo. However, there was a significant decrease in CRP (high sensitivity assay) in) in the IMT group compared to the placebo group. Conclusion: Immune modulation therapy did not improve walking distance in patients with symptomatic peripheral arterial disease but the decrease in CRP suggests a biologic effect of IMT and will warrant further study.

Reference: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Immune Modulation Therapy in Patients with Symptomatic Peripheral Arterial Disease: The SIMPADICO Trial. Author: Jeffrey W. Olin, Mount Sinai School of Medicine, New York, NY. Presented at Smaller Trial Late-Breaking Clinical trials I, Sunday March 12, 2006. American College of Cardiology 55th Annual Scientific Sessions, March 11-14, 2006, Atlanta, GA.

Being tested
Celacade™ system
Keywords
Intermittent Claudication, Peripheral Arterial Disease, Immune modulation therapy, Inflammation
Medical subject headings
Peripheral Arterial Disease, Arterial Occlusive Diseases, Intermittent Claudication, Inflammation

What participants receive

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

  • Celacade™ systemDevice

What is being measured

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

  1. Absolute claudication distance (ACD)

Secondary outcomes (3)

  1. Health-related quality of life

  2. Functional status

  3. Combined incidence of peripheral arterial disease (PAD)-related clinical outcomes

Timeline

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

  1. First posted26 May 2005 (estimated)
  2. Study startJan 2003
  3. Study completionDec 2005

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
500 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111826
Sponsor's protocol ID
0101
Status last verified
Nov 2007
First submitted
25 May 2005
Last updated
31 Mar 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Celacade™ system in people with Peripheral Arterial Disease and Arterial Occlusive Diseases, run by Vasogen.

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 5 inclusion and 15 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 31 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early. Results are not available in the source record.

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?

Absolute claudication distance (ACD). 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 NCT00111826.

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 31 Mar 2010.

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