Neurostimulation to Treat Refractory Angina Pectoris Pain (STARTSTIM)

Medtronic

Status and phase: Terminated; Phase 3

Conditions: Angina Pectoris

Treatments: Device: Spinal Cord Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00200070

1659

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)