Feasibility Study of Photopheresis Post Angioplasty

NCT00157001 | Terminated Phase 2 DMC

• 1 other identifier: R98-09-013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

Photopheresis Post Angioplasty PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlantic Health System: lead
• Therakos: collaborator

Study Sites (1)

Morristown Memorial Hospital

Morristown, New Jersey, 07962-1956, United States

Location

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emil Bisaccia, MD

  Morristown Memorial Hospital-Atlantic Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: August 1, 2000
• Study Completion: April 1, 2007
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

US (1)