Status:
UNKNOWN
Spinal Cord Stimulation (SCS) in Refractory Angina
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Angina Pectoris
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
The study aims at assessing safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study. Sixty patients with...
Detailed Description
Aim of the study is to assess safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study. The study also ass...
Eligibility Criteria
Inclusion
- Stable angina pectoris refractory to optimal medical therapy, with at least 10 angina episodes in the three weeks previous SCS implant;
- Documentation of coronary artery disease and reversible myocardial ischaemia;
- Patient is not a candidate for or refuses surgical or percutaneous coronary revascularization;
- Availability for follow-up visits;
- Written informed consent.
Exclusion
- Severe spinal cord diseases that prevent the catheter positioning in the epidural space;
- No paresthesic coverage of angina pain area during SCS;
- Unstable angina pectoris;
- Female patients in fertile age;
- Enrolment in other studies;
- Need for anticoagulant therapy;
- Patients needing diathermy treatment;
- Life expectancy \<12 months.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00121654
Start Date
July 1 2005
End Date
December 1 2009
Last Update
March 10 2009
Active Locations (1)
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1
Istituto di Cardiologia - Università Cattolica del Sacro Cuore
Roma, Italy, 00168