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Feasibility Study of Photopheresis Post Angioplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157001
Recruitment Status : Terminated
First Posted : September 12, 2005
Last Update Posted : January 16, 2014
Information provided by:
Atlantic Health System

Brief Summary:

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:

  1. To compare the incidence of major adverse cardiac events (MACE) between the three treatment groups for 6 months post-angioplasty. MACE events include death (cardiac related), myocardial infarction, coronary artery bypass graft surgery, repeat angioplasty to the target vessel, hospitalization and clinical symptoms.
  2. To evaluate the safety of the treatment by comparing the incidence of acute and subacute thrombosis, bleeding and vascular complications and other non-MACE events every 2 weeks for 6 months post-angioplasty between the three treatment groups.

Condition or disease Intervention/treatment Phase
Stable Angina Pectoris Unstable Angina Pectoris Silent Ischemia Procedure: Photopheresis Post Angioplasty Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility Study of Photopheresis Post Angioplasty
Study Start Date : August 2000
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Primary Outcome Measures :
  1. The primary objective of the study is to evaluate the difference in 6-month restenosis rates in the treatment of at least a single or multiple de novo coronary artery lesion by photopheresis as an adjunct to angioplasty plus stent insertion in comparison

Secondary Outcome Measures :
  1. The primary endpoint will be the six month composite incidence of death from any cause: nonfatal myocardial infarction, ischemia documented by treadmill exercise testing with or w/o nuclear myocardial imaging, or the need for a repeat revascularization.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have a single or multiple de novo coronary artery lesion with 70% stenosis intended to be treated by PTCA using balloons, laser or atherectomy devices plus stent insertion.
  • Patients with stable angina pectoris or unstable angina pectoris
  • Patients must have veins with adequate access for photopheresis.

-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.

  • Patients must be willing to return for evaluation every two weeks and for all photopheresis treatments if in Groups 2, 3.
  • Patients must sign an informed consent form prior to entry into the study.
  • Patients must live within commuting distance of the treatment center.
  • Patients must not be treated with any other investigational drug or device within 6 months prior to participation in this 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:

  • Patients who cannot tolerate extracorporeal volume loss during the leukocyte enrichment phase.
  • Patients with photosensitive disease, such as porphyria or systemic lupus erythematous. Care must be taken in selecting patients who require drugs either topically or systemically during the course of the study with photosensitizing potential, such as phenothiazine, tetracycline, sulfonamides or chlorothiazide. Patients who must take photosensitizing drugs will not receive them prior to each photopheresis treatment.
  • Patients with renal insufficiency (creatinine >3.0 mg/dl).
  • Patients who are pregnant or nursing a child.
  • Patients with a severe coexisting medical, physiological or sociological condition that in the opinion of the investigators would preclude any of the procedures contained in this protocol.
  • Patients who exhibit idiosyncratic or hypersensitivity reactions to psoralen compounds.
  • Patients with a platelet count < 50,000/mm.
  • Patients with active hepatitis.
  • Patients with hemoglobin < 9 or hematocrit <27.
  • Patients under age 18.
  • Patients with ostial lesions.
  • Patients who are insulin-dependent diabetics.
  • Patients who have had an acute myocardial infarction within the previous 8 weeks. is (CCS Class 1, 2, or 4 and Braunwald Class 1-3, B-C) or document silent ischemia.
  • Patents must have evidence of left ventricular ejection fraction of >30%.
  • Patients must have a hematocrit >27 and hemoglobin >9.
  • Patients must be at least 18 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157001

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United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Sponsors and Collaborators
Atlantic Health System
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Principal Investigator: Emil Bisaccia, MD Morristown Memorial Hospital-Atlantic Health System
Layout table for additonal information Identifier: NCT00157001    
Other Study ID Numbers: R98-09-013
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Angina, Unstable
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations