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

Last updated: August 8, 2022
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05394649
RBHP 2021 HONTON
  • Ages > 18
  • All Genders

Study Summary

The ICARE trial will aim to assess the efficacy of rotational atherectomy by Rotablator and Intravascular Lithotripsy by C2 Shockwave Medical® (IVL) in a randomized fashion in highly calcified lesions measured by final minimal stent area (MSA) on Optical Frequency Domain Imaging (OFDI). The investigator hypothesize that there will be no significant difference in final MSA in OFDI between the two groups after angioplasty with a last generation drug eluting stent ULTIMASTER TANSEI.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient ≥ 18 years old
  2. Subjects with native coronary artery disease (including stable or unstable angina andsilent ischemia) suitable for Percutaneous Coronary Intervention (PCI)
  3. For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) mustbe less than or equal to the upper limit of the lab (URL) normal within 12 hours priorto the procedure
  4. The target lesion must be a de novo coronary lesion that has not been previouslytreated with any interventional procedure
  5. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or oftheir branches) with:
  6. Stenosis of ≥70% and <100%
  7. or Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia viapositive stress test, or fractional flow reserve value ≤0.80
  8. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
  9. The lesion length must not exceed 40 mm
  10. The target vessel must have TIMI flow 3 at baseline
  11. Evidence of calcification at the lesion with a B or C Mintz classification site: B: Moderate calcification: radiopacities are noted only during the cardiac cyclebefore contrast injection C: severe calcification: radiopacities are seen withoutcardiac motion, also before contrast injection, usually affecting both sides of thearterial lumen.
  12. Ability to pass a 0.014" guidewire across the lesion
  13. Ability to cross target lesion with a 2 mm balloon
  14. Patient insured under the French healthcare system ("Régime National AssuranceMaladie")
  15. Lesions in non-target vessels requiring PCI may be treated either:
  • a. >30 days prior to the study procedure if the procedure was unsuccessful orcomplicated; or
  • b. >24 hours prior to the study procedure if the procedure was successful anduncomplicated (defined as a final lesion angiographic diameter stenosis <30% andTIMI 3 flow (visually assessed) for all non-target lesions and vessels withoutperforation, cardiac arrest or need for defibrillation or cardioversion orhypotension/heart failure requiring mechanical or intravenous hemodynamic supportor 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 thediagnosis coronarography with respect of the delay for the index procedure of theprotocol as described above
  1. Patient able to assess and understand the risks and benefits, to accept andparticipate in the study (by signing an informed consent form and knowledgeable of theinformation letter).
  2. Patient accepting the appropriate follow-up as per study definition

Exclusion

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, includingfollow-up visits
  5. The protected subject according to the current legislation (articles L.1121-5 toL.1121-8 of the French Code of Public Health).
  6. The subject is participating in another research study involving an investigationalagent (pharmaceutical, biologic, or medical device), unless it is authorized by theconcomitant 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 adequatelypre-medicated
  9. The subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to indexprocedure, defined as a clinical syndrome consistent with an acute coronary syndromewith 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 priorintracranial 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 eitherfever, 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 teamhas met and recommends PCI is the most appropriate treatment for the patient
  21. Definite or possible thrombus (by angiography or intravascular imaging) in the targetvessel
  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 througha saphenous vein or arterial bypass graft
  25. Angiographic evidence of dissection in the target vessel at baseline or afterguidewire 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

Study Design

Total Participants: 178
Study Start date:
August 04, 2022
Estimated Completion Date:
May 31, 2025

Study Description

Calcified coronary lesions will increase in daily percutaneous coronary intervention regarding the significant epidemiological increase of factors leading to coronary calcifications, such as hypertension, aging, and diabetes. Furthermore, calcified lesions are underdiagnosed in angiography as shown by intra-coronary imaging studies (either by OCT or IVUS), which reported that significant calcium deposits might be present in 76-83% of lesions. Calcified lesions are associated with a larger amount of periprocedural complications, as well as a poorer clinical prognosis. Standard techniques to prep the calcified plaque, such as rotational or orbital atherectomy, still have low penetration and are associated with an increase in periprocedural complications without clear clinical evidence of efficacy. More recently, there has been a growing interest in intravascular lithotripsy (IVL), which appears as an appealing option with recently published data with evidence for a safe procedure but without robust data on efficacy (sample size population, debatable effectiveness endpoint…). Although the European Society of Cardiology highlights in the latest myocardial revascularization guidelines the need for lesion preparation before stent implantation on short- and long-term clinical outcomes, no specific recommendation has been given on the use of the dedicated devices to prepare the plaque, including atherectomy, which is left to the operator assessment.

Connect with a study center

  • Groupe SAnté Victor Pauchet

    Amiens,
    France

    Site Not Available

  • Clinique Rhône Durance

    Avignon,
    France

    Site Not Available

  • CHU Jean Minjoz

    Besançon,
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux,
    France

    Site Not Available

  • Clinique Saint Augustin

    Bordeaux,
    France

    Site Not Available

  • CHU Clermont-Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • GH Mutualiste Grenoble

    Grenoble,
    France

    Site Not Available

  • Institut Cardiologique Paris sud

    Massy,
    France

    Site Not Available

  • Clinique du Millénaire

    Montpellier,
    France

    Site Not Available

  • Clinique Pasteur

    Nancy,
    France

    Site Not Available

  • Nouvelle Clinique Nantaise

    Nantes,
    France

    Site Not Available

  • CHU Nîmes

    Nîmes,
    France

    Site Not Available

  • Hôpital Européen de Paris GVM la Roseraie

    Paris,
    France

    Site Not Available

  • Institut Mutualiste Montsouris

    Paris,
    France

    Site Not Available

  • CHU Poitiers

    Poitiers,
    France

    Site Not Available

  • Clinique Saint Hilaire

    Rouen,
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse,
    France

    Site Not Available

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