Neurostimulation to Treat Refractory Angina Pectoris Pain

Phase 3

Terminated

• Conditions: Angina Pectoris

• Registration Number: NCT00200070
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-26
• Last Update Posted: 2010-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 228

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function.

Trial Locations

Locations (1)

Contact Medtronic for Exact Location; 🇨🇦 Ottawa, Ontario, Canada