Angina Pectoris
Conditions
Keywords
Angina Pectoris Pain
Brief summary
The therapy under investigation involves an implanted Medtronic neurostimulation system to relieve symptoms of angina pectoris pain. Electrical impulses are applied to targeted areas of the spinal cord through an implanted lead (a flexible insulated wire) that is powered by an implanted battery.
Interventions
DEVICESpinal Cord Stimulation
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* stable angina pectoris associated with reversible myocardial ischemia and significant coronary artery disease (CAD) * classified as Canadian Cardiovascular Society (CCS) angina class III or IV * refractory angina despite receiving optimal/maximal medical treatment * not a candidate for bypass surgery, angioplasty or stent
Exclusion criteria
* not able to perform exercise treadmill testing * previously received therapeutic transcutaneous electrical nerve stimulation (TENS) (within 2 years) or any spinal cord stimulation (SCS) * has an implanted pacemaker/defibrillator (ICD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function. | — |
Countries
Canada, United States
Outcome results
None listed