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NCT00157001 · ClinicalTrials.gov registry record · Phase 2
Feasibility Study of Photopheresis Post Angioplasty
A Phase 2 study, sponsored by Atlantic Health System.
- Terminated
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT00157001 is a Phase 2 study that was terminated before completion, run by Atlantic Health System. The registered enrollment target is 120 participants.
The verdict
NCT00157001, a Phase 2 study, was terminated before completion, sponsored by Atlantic Health System.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
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.
Interventions
- PROCEDURE Photopheresis Post Angioplasty
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2000-08 |
| Est. Completion | 2007-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00157001
The ClinicalTrials.gov registry entry for NCT00157001 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atlantic Health System, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Photopheresis Post Angioplasty is the first listed.
NCT00157001 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00157001 about?
NCT00157001 is a clinical study titled "Feasibility Study of Photopheresis Post Angioplasty". 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 agai...
What is the current status of trial NCT00157001?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2000-08. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00157001?
The interventions under investigation include: Photopheresis Post Angioplasty (PROCEDURE).
Who is sponsoring clinical trial NCT00157001?
This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.
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