BM Shockwave Devices Clinical Study in Coronary Calcified Lesions
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBrosMed Medical Co., Ltd
About this trial
This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.
Eligibility criteria
Qualifiers
Age 18-85 years, male or female;
Patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction;
Patient is able and willing to comply with all assessments in the study.
The target lesion is a de novo, in-situ coronary artery lesion;
Disqualifiers
ST-segment elevation myocardial infarction within 3 days prior to the procedure;
Use of rotational atherectomy or special balloons (chocolate balloon, scoring balloon, cutting balloon, etc.) for lesion pretreatment;
New York Heart Association (NYHA) functional class III or IV;
Target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or percutaneous transluminal coronary angioplasty (PTCA) treatment;
Trial design
Treatments tested in this trial
- BM shockwave devices
Treatment groups
198 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov