Intravascular Lithotripsy in Comparison to Rotational Atherectomy: An Evaluation by OFDI

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · May 24, 2022

Keywords

ClinConnect Summary

The ICARE trial is studying two different treatments for patients with heart artery blockages that have significant calcium buildup. The two treatments being compared are Intravascular Lithotripsy (IVL), which uses sound waves to break up the calcium, and Rotational Atherectomy, which physically grinds away the blockage. The trial aims to see if there is any difference in the effectiveness of these treatments by measuring how well they open the artery after a stent is placed.

To participate in this trial, patients must be at least 18 years old and have specific types of coronary artery disease that can be treated with a procedure called Percutaneous Coronary Intervention (PCI). This includes patients with blockages that are 70% or more narrowed, and those with less severe blockages if they are causing symptoms. Participants should expect to undergo a procedure where one of the two treatments will be used, and they will be monitored afterward. It's also important to note that participants need to be covered by the French healthcare system and agree to follow-up visits as part of the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient ≥ 18 years old
• • 2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI)
• • 3. For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of the lab (URL) normal within 12 hours prior to the procedure
• • 4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
• 5. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or of their branches) with:
• • 1. Stenosis of ≥70% and \<100%
• • 2. or Stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80
• • 6. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
• • 7. The lesion length must not exceed 40 mm
• • 8. The target vessel must have TIMI flow 3 at baseline
• 9. Evidence of calcification at the lesion with a B or C Mintz classification site:
• • B: Moderate calcification: radiopacities are noted only during the cardiac cycle before contrast injection C: severe calcification: radiopacities are seen without cardiac motion, also before contrast injection, usually affecting both sides of the arterial lumen.
• • 10. Ability to pass a 0.014" guidewire across the lesion
• • 11. Ability to cross target lesion with a 2 mm balloon
• • 12. Patient insured under the French healthcare system ("Régime National Assurance Maladie")
• 13. Lesions in non-target vessels requiring PCI may be treated either:
• • a. \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
• • b. \>24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis \<30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation \>normal; or
• • c. \>30 days after the study procedure d. Could be treated in the same time of the diagnosis coronarography with respect of the delay for the index procedure of the protocol as described above
• • 14. Patient able to assess and understand the risks and benefits, to accept and participate in the study (by signing an informed consent form and knowledgeable of the information letter).
• • 15. Patient accepting the appropriate follow-up as per study definition
• Exclusion Criteria:
• • 1. Patient age \< 18 years
• • 2. The subject is pregnant or nursing
• • 3. Patient refusing to participate in the study or unable to give informed consent (Guardianship, curatorship or judicial safeguard)
• • 4. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
• • 5. The protected subject according to the current legislation (articles L.1121-5 to L.1121-8 of the French Code of Public Health).
• • 6. The subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device), unless it is authorized by the concomitant study protocol.
• • 7. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months
• • 8. The subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
• • 9. The subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK-MB greater than 1 time the local laboratory's upper normal limit
• • 10. New York Heart Association (NYHA) class III or IV heart failure
• • 11. History of a stroke or Transient Ischemic Attack (TIA) within 6 months, or any prior intracranial hemorrhage
• • 12. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
• • 13. Uncontrolled diabetes defined as an HbA1c \>10%
• • 14. Subjects in cardiogenic shock
• • 15. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
• • 16. Subjects with a life expectancy of less than 1 year
• • 17. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA, or PFO occlusion...) within 30 days prior to the index procedure
• • 18. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion...)
• • 19. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
• • 20. High SYNTAX Score (≥33) if assessed as a standard of care, unless the local heart team has met and recommends PCI is the most appropriate treatment for the patient
• • 21. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
• • 22. Evidence of aneurysm in target vessel within 10 mm of the target Lesion
• • 23. Unprotected left main
• • 24. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
• • 25. Angiographic evidence of dissection in the target vessel at baseline or after guidewire passage
• • 26. Ejection fraction less than 30 % evaluated in TTE, angiography or MRI
• • 27. Patient suffering of lymphoma, leukemia and other malignancies
• • 28. Patient suffering of liver disease