The Safety and Performence of ShockPulse-10 in Patients with Coronary Artery Calcification
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeya Medical
About this trial
This study is an exploratory, multicenter, single-group clinical trial aimed to evaluate the clinical outcomes of using ShockPulse-10 in the treatment of coronary artery calcification .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is ≥ 18 years of age;
Patients with significant coronary artery disease (including stable or unstable angina and asymptomatic myocardial ischemia) who are suitable for PCI treatment;
A single newly developed stenosis of the target vessel, which is the left anterior descending artery, right coronary artery, or circumflex artery (or its branches), with stenosis degree ≥70% or ≥50% (Visually inspect ) and accompanied by evidence of ischemia;
The target lesion is a primary, in situ coronary artery lesion;
Disqualifiers
Left ventricular ejection fraction < 40%；
NYHA class III or IV heart failure；
Patients with single coronary artery supply;
Patients with evidence of dissection at the site of the lesion on imaging;
Trial design
Design model
Single group
Treatments tested in this trial
Shockplus-10
DevicePatients with coronary artery calcification who are planned to undergo PCI and are deemed in need of ShockPulse-10 treatment by their physicians
Treatment groups
205 Participants
are divided into 1 treatment groupGroup A: DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Procedure success
Procedure success defined as successful stent implantation, residual stenosis degree ≤30% , and no major adverse cardiac events (MACE) occurring during hospitalization
Time frame
immediately post-procedure or prior to discharge, whichever comes first2
Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure
Freedom from major adverse cardiac events (MACE) within 30(±7days) days of the index procedure；MACE is defined as:Cardiac death; or Myocardial Infarction (MI): or Target Vessel Revascularization
Time frame
30（±7days）days post index procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov