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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

228

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Dec 2002

Typical duration for phase_3

Geographic Reach

2 countries

8 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.3 years study duration

Study Start

First participant enrolled

December 1, 2002

Completed

2.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed

Last Updated

August 30, 2010

Status Verified

August 1, 2010

Enrollment Period

4.3 years

First QC Date

September 12, 2005

Last Update Submit

August 26, 2010

Conditions

Angina Pectoris

Keywords

Angina Pectoris Pain

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Spinal Cord StimulationDEVICE

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.