Feasibility Study of Photopheresis Post Angioplasty

This study has been terminated.
Sponsor:
Collaborator:
Therakos
Information provided by:
Atlantic Health System
ClinicalTrials.gov Identifier:
NCT00157001
First received: September 8, 2005
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Stable Angina Pectoris
Unstable Angina Pectoris
Silent Ischemia
Procedure: Photopheresis Post Angioplasty
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility Study of Photopheresis Post Angioplasty

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 120
Study Start Date: August 2000
Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157001

Locations
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Sponsors and Collaborators
Atlantic Health System
Therakos
Investigators
Principal Investigator: Emil Bisaccia, MD Morristown Memorial Hospital-Atlantic Health System
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157001     History of Changes
Other Study ID Numbers: R98-09-013
Study First Received: September 8, 2005
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Ischemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on July 09, 2014