Shockwave treatment for advanced angina in Maastricht (SWAAM). A double blind randomised study.

Phase 2

Completed

• Conditions: chronic angina pectoris; end stage coronary artery disease; 10011082

• Registration Number: NL-OMON36845
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

Chronic angina pectoris CCS III or IV with documented reversible ischemia and/or hibernation
patients demonstrates exercise tolerance time (ETT) duration < 10 minutes on a modified Bruce protocol
revascularisation by CABG or PCI is exhausted
patient's condition stable for at least 3 months
life expectancy of > 12 months

Exclusion Criteria

unstable angina pectoris
haemodynamically significant valvular heart disease
myocardial infarction < 3 months
evidence of intracardiac thrombus
patient participating in another study
age < 18 years
pregnancy
cardiac or pulmonary malignancy
no informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>improvement of exercise tolerance</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>improvement of myocardial perfusion and improvement of quality of life</p><br>