Comparing two methods for treating calcified coronary lesions

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

This study is testing which of two treatments, intravascular lithotripsy or rotational atherectomy, works better for people with hard-to-treat calcified coronary artery blockages.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Clermont-Ferrand (Academic / other)
• Locations: 17 sites (Amiens and 16 other locations)
• Trial ID: NCT05394649 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of two techniques, intravascular lithotripsy and rotational atherectomy, for treating highly calcified coronary lesions. Patients with native coronary artery disease suitable for percutaneous coronary intervention will be randomly assigned to receive one of the two treatments. The primary outcome will be the final minimal stent area measured by Optical Frequency Domain Imaging after angioplasty with a drug-eluting stent. The study aims to determine if there is a significant difference in efficacy between the two methods.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with untreated de novo coronary lesions suitable for percutaneous coronary intervention.

Not a fit: Patients with previously treated lesions or those with significant comorbidities that preclude safe intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with calcified coronary lesions, potentially reducing complications and enhancing stent placement efficacy.

How similar studies have performed: While there is emerging interest in intravascular lithotripsy, the comparative efficacy of these two approaches has not been extensively tested in prior studies.

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

Where this trial is running

Amiens and 16 other locations

• Groupe SAnté Victor Pauchet — Amiens, France (Not_yet_recruiting)
• Clinique Rhône Durance — Avignon, France (Not_yet_recruiting)
• CHU Jean Minjoz — Besançon, France (Not_yet_recruiting)
• CHU Bordeaux — Bordeaux, France (Not_yet_recruiting)
• Clinique Saint Augustin — Bordeaux, France (Not_yet_recruiting)
• CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
• GH Mutualiste Grenoble — Grenoble, France (Not_yet_recruiting)
• Institut Cardiologique Paris sud — Massy, France (Not_yet_recruiting)
• Clinique du Millénaire — Montpellier, France (Not_yet_recruiting)
• Clinique Pasteur — Nancy, France (Not_yet_recruiting)
• Nouvelle Clinique Nantaise — Nantes, France (Not_yet_recruiting)
• CHU Nîmes — Nîmes, France (Not_yet_recruiting)
• Hôpital Européen de Paris GVM la Roseraie — Paris, France (Not_yet_recruiting)
• Institut Mutualiste Montsouris — Paris, France (Not_yet_recruiting)
• CHU Poitiers — Poitiers, France (Not_yet_recruiting)
• Clinique Saint Hilaire — Rouen, France (Not_yet_recruiting)
• Clinique Pasteur — Toulouse, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Lise Laclautre

Conditions Intravascular Lithotripsy; Rotational Atherectomy; OFDI