Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Vasogen |
---|---|
Information provided by: | Vasogen |
ClinicalTrials.gov Identifier: | NCT00111826 |
The purpose of this study is to assess the effects of the Celacade™ system in patients with intermittent claudication.
Condition | Intervention | Phase |
---|---|---|
Peripheral Arterial Disease Arterial Occlusive Diseases Intermittent Claudication |
Device: Celacade™ system |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 500 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | December 2005 |
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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 0101 |
Study First Received: | May 25, 2005 |
Last Updated: | November 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00111826 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Intermittent Claudication Peripheral Arterial Disease Immune modulation therapy Inflammation |
Arterial Occlusive Diseases Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases |
Neoplasm Metastasis Intermittent Claudication Arteriosclerosis Inflammation |
Cardiovascular Diseases |