Using shockwave therapy to reduce coronary artery calcification

Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT

This study is testing if shockwave therapy can help reduce calcium buildup in the arteries of patients who need heart procedures.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Rome Tor Vergata (other)
• Locations: 1 site (Roma, Rome)
• Trial ID: NCT05973994 on ClinicalTrials.gov

What this trial studies

This observational, multicenter study aims to investigate the effects of intravascular lithotripsy on coronary artery calcifications in patients with significant stenosis who are candidates for percutaneous coronary intervention (PCI). The study will utilize optical coherence tomography (OCT) to assess changes in calcium density before and after treatment. By analyzing images of the affected coronary arteries, researchers will quantify the reduction in calcium density in the targeted regions. The findings could provide insights into the effectiveness of this novel treatment approach.

Who should consider this trial

Good fit: Ideal candidates include patients with native coronary artery disease suitable for PCI and specific eligibility criteria regarding heart function and lesion characteristics.

Not a fit: Patients with previously treated coronary lesions or those unable to tolerate dual antiplatelet therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with coronary artery disease by effectively reducing calcified plaques.

How similar studies have performed: While the approach of using intravascular lithotripsy is relatively novel, similar studies have shown promising results in addressing coronary artery calcification.

Eligibility criteria

Inclusion Criteria:

* Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
* Left ventricular ejection fraction (LVEF) ≥35% as measured prior to enrollment
* eGFR ≥45 ml/min (Cockroft-Gault, MDRD)
* Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure or if troponin is elevated, concomitant CK must be normal
* Ability to tolerate dual antiplatelet therapy (i.e. aspirin and clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patient not on oral anticoagulation) and single antiplatelet therapy for life
* The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
* Single de novo target lesion stenosis of LAD, RCA or LCX (or of their branches) with stenosis of ≥70% and \<100% or stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR \<0.89 or IVUS or OCT minimum lumen area ≤4.0 mm²
* Reference vessel must have 2.5 mm - 4.0 mm diameter and ≤ 30 mm length
* Evidence of calcification at the lesion site assessed by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, or by IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
* Planned treatment of single lesion for every target vessel
* Ability to pass a 0.014" guide wire across the lesion
* The target vessel must have a TIMI flow 3 at baseline

Exclusion Criteria:

* Left ventricular ejection fraction (LVEF) \<35%
* Subject is pregnant or nursing
* eGFR \<45 ml/min (Cockroft-Gault, MDRD) or chronic dialysis
* Untreated pre-procedural haemoglobin \<9 g/dL or intention to refuse blood transfusions if one should become necessary
* Patient has a platelet count \<100,000 cells/mm3 or \>750,000 cells/mm3
* Patient has a known allergy to protocol required medications (clopidogrel, thienopyridines, aspirin, contrast media) that cannot be adequately premedicated
* Uncontrolled diabetes defined as a fasting hyperglycaemia \>200 mg/dL or HbA1c greater than or equal to 10%
* Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
* Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding
* Patient has a history of coagulopathy
* Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
* Subjects with a life expectancy of less than 1 year
* Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
* Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
* Stent implantation in the target vessel within the last year or a stent within 10 mm of the target lesion
* Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
* Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Where this trial is running

Roma, Rome

• University of Rome Tor Vergata - Policlinico — Roma, Rome, Italy (RECRUITING)

Study contacts

• Principal investigator: Giuseppe M Sangiorgi, Professor — University of Rome Tor Vergata
• Study coordinator: Giuseppe M Sangiorgi, Professor

Conditions: Coronary Artery Calcification, Coronary artery calcification, Intravascular Lithotripsy, Optical Coherence Tomography, Calcium density