Clinical Trial: Comparison of SCS and PMR in Patients With Refractory Angina Pectoris
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Open Single-Centre Parallel Randomised Trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Revascularisation (PMR) in Patients With Refractory Angina Pectoris
Brief Summary:
Randomised trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in patients with Refractory Angina Pectoris.
Hypothesis: difference in exercise tolerance at 12 months between SCS and PMR
Detailed Summary: The purpose of this open, parallel, single-center prospective, randomised controlled trial is to compare two treatments: Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) and assess their use and longer term effect in patients with Refractory Angina Pectoris.
Sponsor: Medtronic
Current Primary Outcome: Improvement in total exercice time following SCS compared to PMR at 12 months
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Angina measured by the CCS class and the patients subjectives observations
- Morbidity/Mortality
- Quality of life
- Medication consumption
- Difference in myocardial perfusion scanning
- Myocardial ischemia during exercise treadmill testing
- Safety profiles
Original Secondary Outcome: Same as current
Information By: Medtronic
Dates:
Date Received: September 9, 2005
Date Started: September 2000
Date Completion: January 2007
Last Updated: December 15, 2005
Last Verified: September 2005