This trial is active, not recruiting.

Condition refractory angina pectoris
Treatment cardiac extracorporeal shockwave therapy generator (cardiospec)
Phase phase 1
Sponsor Medispec
Collaborator Heart and Diabetes Center North-Rhine Westfalia
Start date January 2008
End date April 2012
Trial size 35 participants
Trial identifier NCT01567644, ESMR-NRW-DE


Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients in this group receive shockwave therapy.
cardiac extracorporeal shockwave therapy generator (cardiospec) Cardiospec
Energy Density - 0.09 mJ/mm2

Primary Outcomes

Change in AP-CCS
time frame: 6 Months

Secondary Outcomes

Exercise tolerance time
time frame: 6 Months
Change in PET scan
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosed with chronic stable angina pectoris. - Documented myocardial segments with reversible ischemia - AP CCS class of III-IV. - Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment. - Exercise tolerance time < 10 min (modified Bruce) - Two ETT tests results (within two weeks) averaging no more than 25% of their mean - Documented epicardial coronary artery disease not amenable to angioplasty or CABG. - Signed an IRB approved informed consent form. - Life expectancy of > 12 months. Exclusion Criteria: - Intraventricular thrombus - Malignancy in the area of treatment - Severe COPD - No smoking during the study procedure - MI less < 3 months prior to treatment - Severe Valvular disease - Child bearing potential

Additional Information

Official title Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
Principal investigator Lothar Faber, Prof. MD
Description Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless. At first, the patient undergoes stress- PET testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Medispec.