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Sponsors and Collaborators: |
Atlantic Health System Therakos |
---|---|
Information provided by: | Atlantic Health System |
ClinicalTrials.gov Identifier: | NCT00157001 |
The primary objective of the study is to evaluate the difference in 6-month restenosis rates in coronary artery lesions treated by photopheresis in addition to angioplasty with stent placement, as opposed to no photopheresis after angioplasty and stent placement. Restenosis means the closing up again, or narrowing in diameter, of the previously treated artery, which may cause reduced blood flow and the re-occurrence of symptoms. Photopheresis is a therapeutic technique in which a portion of your white blood cells is collected by a blood separation device and exposed to ultraviolet A light, in combination with the drug 8-MOP (8-methoxypsoralen), then returned to you.
The secondary objectives are:
Condition | Intervention | Phase |
---|---|---|
Stable Angina Pectoris Unstable Angina Pectoris Silent Ischemia |
Procedure: Photopheresis Post Angioplasty |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Feasibility Study of Photopheresis Post Angioplasty |
Estimated Enrollment: | 120 |
Study Start Date: | August 2000 |
Estimated Study Completion Date: | April 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-Patients must not be pregnant Female patients who are in child- bearing years and have not been surgically sterilized will be tested for pregnancy by a serum HCG test prior to enrollment into the study and must agree to practice contraception during her participation in the study.
Angiographic Inclusion Criteria:
-Patients who have a single or multiple de novo coronary artery lesion with 70% stenosis successfully treated by PTCA plus stent insertion to <50% stenosis as documented by on-line quantitative coronary angiography (QCA).
General Exclusion Criteria:
United States, New Jersey | |
Morristown Memorial Hospital | |
Morristown, New Jersey, United States, 07962-1956 |
Principal Investigator: | Emil Bisaccia, MD | Morristown Memorial Hospital-Atlantic Health System |
Study ID Numbers: | R98-09-013 |
Study First Received: | September 8, 2005 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00157001 |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Heart Diseases Myocardial Ischemia Vascular Diseases Angina Pectoris |
Pain Ischemia Angina, Unstable Chest Pain |
Pathologic Processes Cardiovascular Diseases |