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