Lithoplasty using shock waves for coronary heart disease - G-BA awards contract for test study

22.08.2023 16:11

The Federal Joint Committee (G-BA) commissions the German Heart Center Munich to carry out a test study on coronary lithoplasty for coronary heart disease, a shock wave therapy for calcified coronary arteries. The decision was preceded by a Europe-wide tender process. The G-BA wants to use the study results to evaluate the medical benefits of this novel method on the safest possible basis.

The test study focuses on patients with calcified narrowings or blockages of the coronary arteries: especially those whose vessels cannot be opened sufficiently with a standard balloon catheter to insert a stent. The aim is to investigate which treatment achieves the better results in comparison:

• coronary lithoplasty, in which the calcification in the coronary arteries is broken up with the help of shock waves, or
• alternative percutaneous procedures for the treatment of calcified coronary arteries. These include, for example, balloon catheters with tiny cutting tools (cutting or scoring balloons) or small drill heads with which vessels are passed through before stent insertion (rotablation).

Tasks within the test study

As an independent scientific institution, the German Heart Center Munich has the following tasks in the test study:

• In preparation for the study, the German Heart Center Munich draws up the study protocol and obtains the official approvals necessary to start the study as well as the vote of the ethics committee(s).
• The German Heart Center Munich then selects study centers that will include suitable patients in the study.
• After the study has been completed, the German Heart Center Munich will evaluate the data collected and submit a final report on the study results to the G-BA for further consultation.

The G-BA will provide information on the current status of the study financed by statutory health insurance on its website:  ISAR-WAVE – lithoplasty using shock waves for coronary heart disease

Service providers who want to take part in the trial as study centers can find relevant FAQs, the exact study description and the contact details of the German Heart Center Munich on the linked page.