acute coronary syndrome, chronic coronary syndrome, angina pectoris, calcified coronary lesions coronary artery disease, angina pectoris
Conditions
Interventions
Use of Lithix balloon (Hertz contact intravascular lithotripsy)
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject is aged 18 to 85 years Presentation with stable angina or stable NSTE-ACS with de novo native significant lesion > 70 % stenosis or 50-70 % stenosis with evidence of hemodynamic significanceSignificant calcification is defined either as:> 270° arc of calcium > 5 mm length on high definition intravasculair ultrasound HD-IVUS360° arc of calcium on HD-IVUS
Exclusion criteria
Exclusion criteria: STEMI within 30 daysLVEF < 25 %Cardiogenic shock or anticipated mechanical/pharmacological supportExcessive tortuosity or anatomic considerations precluding intravascular imagingTarget vessel dissection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is device and procedural success.- Device success is defined as HC-IVL balloon delivery and balloon inflation without complications. - Procedural success defined as technical success without in-hospital major adverse cardiovascular events ((MACE): composite of cardiovascular death, myocardial infarction and target vessel revascularization). - Technical success is defined as MSA = 5 in non-left main and MSA = 8 in left main coronary artery with final TIMI 3 flow and residual stenosis <30%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-procedural stent area at the point of maximum calcification as measured by intravascular imaging with HD-IVUS.- Safety endpoints include procedural complications and MACE up to two-year follow-upHD-IVUS characteristics: fractures, MSA, stent area, acute area gain and stent expansion (defined as stent area/ average reference lumen area x 100) Periprocedural complications: flow limiting dissection, perforation, no-reflow, periprocedural myocardial infarction, acute stent thrombosisAngiographic outcomes: acute gain and residual diameter stenosis.Clinical outcomes: MACE, and follow up will be performed at 30 days and at regular intervals up to 2 years after the index procedure. | — |
Countries
Netherlands
Contacts
Public ContactM.A. Schotborgh
St. Antonius Ziekenhuis
Outcome results
None listed