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Spinal Cord Stimulation (SCS) in Refractory Angina

NCT00121654 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-03-10

No results posted yet for this study

Summary

The study aims at assessing safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study.

Sixty patients with refractory angina with new SCS device implantation will be randomized to one of three treatment groups:

* paresthesic SCS;
* subliminal SCS;
* low (non effective) stimulation (control).

Clinical follow-up will be done at 1 and 3 months. Control group patients will then be randomized to paresthesic SCS or subliminal SCS for another 3 months and the 2 groups will be reassessed at 6 months.

Conditions

  • Angina Pectoris

Interventions

DEVICE

Spinal cord stimulation

Under sterile conditions and local anesthesia, the epidural space is punctured at the level of T5-T6 and a quadripolar electrode catheter is introduced and advanced under X-ray control into the epidural space. A suitable position for the electrode catheter is sought for, corresponding to the site where a prickling sensation (paresthesia) is felt and covers the area of radiation of angina pain under neurostimulation. The electrode catheter is connected to an internal pulse generator placed in a subcutaneous abdominal or gluteal pocket through an extension lead connected to the electrode by subcutaneous tunneling.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Gaetano A Lanza, MD · Catholic University of the Sacred Heart

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-12-31
Completion
2009-12-31

Countries

  • Italy

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 NCT00121654 on ClinicalTrials.gov