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NCT00200070 Clinical Trial

Neurostimulation to Treat Refractory Angina Pectoris Pain

Angina Pectoris Clinical Trial

— STARTSTIM  

Official title:
STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00200070
Other study ID # 1659
Secondary ID
Status Terminated
Phase Phase 3
First received September 12, 2005
Last updated August 26, 2010
Start date December 2002
Est. completion date April 2007

Study information
Verified date August 2010
Source MedtronicNeuro
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 228
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Device:
• Spinal Cord Stimulation

Locations
Country Name City State
Canada Contact Medtronic for Exact Location Ottawa Ontario
Canada Contact Medtronic for Exact Location Winnipeg Manitoba
United States Contact Medtronic for Exact Location Boston Massachusetts
United States Contact Medtronic for Exact Location Charleston South Carolina
United States Contact Medtronic for Exact Location Gainesville Florida
United States Contact Medtronic for Exact Location Indianapolis Indiana
United States Contact Medtronic for Exact Location Minneapolis Minnesota
United States Contact Medtronic for Exact Location Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.
Secondary Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function.
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