Comparison of SCS and PMR in Patients With Refractory Angina Pectoris

Medtronic

Status and phase

Terminated

Phase 4

Conditions

Angina Pectoris

Treatments

Procedure: Percutaneous Myocardial Laser Revascularisation (PMR)

Procedure: Spinal Cord Stimulation (SCS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00157742

SPIRIT

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient limiting angina (CCS III or IV) despite maximally tolerated medical therapy
Documented coronary artery disease (within the last 9 months prior baseline), which is unsuitable for conventional revascularisation techniques
Patient has documented reversible ischemia on nuclear scan (Tc-99 sestamibi)
Patient is limited in daily activities, primarily exercice capability, by their angina pain
Age 18 or older
Patient must understand the therapy and give informed consent
Patient must be available for appropriate follow-up times for length of Study
Non pregnant woman

Exclusion criteria

Not candidate for surgical implantation of SCS and/or not for PMR and/or unable to use SCS device appropriately for treatment
Patient who has had one or more major cardiac events within 2 months
Patient with myocardial wall thickness< 8 mm in the ischaemic area to be treated as verified by echocardiography
Patient with extensive peripheral vascular disease that precludes vascular access required for PMR
Patient on intravenous therapy to control their symptoms
Patient who is unlikely to survive for more than 12 months due to non cardiac condition e.g.malignancy
patient who has other diseases that are considered of greater clinical significance than the angina pectoris that would impact the ability of the clinician to adequately assess the incremental effects of the trial treatment
Patient with ejection fraction of less than 30 % as verified by echocardiography
Patient with cause of angina other than coronary artery disease (e.g. syndrome "X" patient)
Patient who are unable to perform treadmill exercice test per protocol
Patient who was previously enrolled in this study, or is currently in another clinical study, which will interfere with this protocol
Patient who has has SCS , a TMLR or PMR procedure in the past
Patient with an implanted pacemaker or defibrillator
Patient who has medical conditions which may require Magnetic resonance Imaging (MRI)
Patient with history of dementia or other persisting mental disorders significantly interfering with ability to cooperate or comply with the requirements of the study or comprehend informed consent
Patient with history of Alcohol og Drug abuse