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Feasibility Study of Photopheresis Post Angioplasty

NCT00157001 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-01-16

No results posted yet for this study

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.

Conditions

  • Stable Angina Pectoris
  • Unstable Angina Pectoris
  • Silent Ischemia

Interventions

PROCEDURE

Photopheresis Post Angioplasty

Sponsors & Collaborators

  • Therakos

    collaborator INDUSTRY

  • Atlantic Health System

    lead OTHER

Principal Investigators

  • Emil Bisaccia, MD · Morristown Memorial Hospital-Atlantic Health System

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-08-31
Completion
2007-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00157001 on ClinicalTrials.gov