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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Peripheral Arterial Occlusive Disease
Trial Information
SIMPADICO: Protocol 0101
We are conducting a clinical research study to evaluate the
effectiveness and safety of a novel therapy in patients with
blocked arteries in the legs. The purpose of this research is to
evaluate whether this new treatment will improve your ability to
walk without discomfort. It has been studied in more than 400
patients thus far, including approximately 120 patients with
blocked arteries in the legs.
A total of 500 patients at 60 medical centers in the United States
and Canada will be asked to participate in this study. Mount Sinai
Hospital expects to enroll at least 20 individuals in the study.
Studies in Europe suggest that this type of therapy may be helpful
in increasing walking distance and decreasing pain in patients with
blocked arteries in their legs.
All procedures related to this study will be at no cost to you or
your insurance.
No Compensation Provided
Patient Inclusion/Exclusion Criteria:
1. Age >40 years old
2. History of Intermittent Claudication (pain in legs) due to
peripheral arterial disease
3. Walking distance limited by intermittent claudication
1. Women who are pregnant, lactating, or of childbearing
potential not using accepted contraceptive methods.
2. Hepatitis, HIV, AIDS, serious active infections,
gastrointestinal tract bleeding.
3. Gangrene
4. Buerger's disease
5. Malignancy within five years prior to screening. Patients with
basal cell carcinoma or carcinoma insitu of the cervix will not be
excluded.
6. Organ transplant
7. Allergy to sodium citrate, or any &qout;caine&qout; type
of local anesthetic.
Patricia M. Mcmullen, RN, NP
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Phone: 212 241-0740
Fax: 212 241-5107
EMail: patricia.mcmullen@msnyuhealth.org
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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