CAlcified Lesion Intervention Planning Steered by OCT.

Last updated: November 14, 2022
Sponsor: Institut Mutualiste Montsouris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scleroderma

Treatment

N/A

Clinical Study ID

NCT05301218
CARDIO 04 2021
  • Ages 18-100
  • All Genders

Study Summary

Calcified lesions are very frequent among coronary artery disease stenotic lesions.

The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.

Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.

The presence of calcifications increases the risk of adverse evolution after PCI , including stent restenosis, thrombosis and need for repeat revascularisation. Specific and appropriate tools can be used for calcified lesions management , including high pressure non compliant balloons, intravascular lithotripsy and rotablator. Intra vascular OCT has a high sensitivity and specificity for calcium detection among coronary artery lesions. Compared to IVUS, OCT allows a better quantification of calcium sheets (depth extension ) . Several intra coronary imaging based calcified lesions management algorithms have been proposed , but none have been validated in clinical practice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient with chronic coronary syndrome
  2. Angiographically moderately to severely calcified target lesion, defined as follows:
  • Moderate: lesion with radio-opacities noted only during the cardiac cycle beforecontrast dye injection (Aksoy et al., Circ Cardiovasc Interv 2019)
  • Severe: lesion with radio-opacities seen without cardiac motion before contrastdye injection, visible on both sides of the arterial lumen(Aksoy et al., CircCardiovasc Interv 2019)
  1. Possibility to cross the target lesion with OCT catheter

Exclusion

Exclusion Criteria:

  1. On-going cardiogenic shock
  2. Acute coronary syndrome related to target lesion
  3. Severe renal failure (Creatinine clearance: 30 ml/min/m2)
  4. Impossibility to cross target lesion with OCT catheter & balloons,
  5. Indication for Rotablator device as first line therapy
  6. Pregnancy
  7. Age < 18 y
  8. Denial to provide consent

Study Design

Total Participants: 140
Study Start date:
December 15, 2021
Estimated Completion Date:
December 15, 2023

Connect with a study center

  • Institut Mutualiste montsouris

    Paris, Ile De France 75014
    France

    Active - Recruiting

  • Ch de Bastia

    Bastia, 20600
    France

    Active - Recruiting

  • CHU de Besançon

    Besançon, 25000
    France

    Active - Recruiting

  • CHU de Bordeaux

    Bordeaux, 33000
    France

    Active - Recruiting

  • Clinique Saint Augustin

    Bordeaux, 33200
    France

    Active - Recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • Hôpital Louis Pasteur

    Le Coudray, 28630
    France

    Active - Recruiting

  • L'Hôpital Privé du Confluent

    Nantes, 44000
    France

    Active - Recruiting

  • CHU Nîmes

    Nîmes, 30029
    France

    Active - Recruiting

  • Polyclinique les Fleurs

    Ollioules, 83190
    France

    Active - Recruiting

  • CHU de Poitiers

    Poitiers, 86000
    France

    Active - Recruiting

  • Clinique Saint-Hilaire

    Rouen, 76000
    France

    Active - Recruiting

  • Institut Arnaud Tzanck,

    Saint-Laurent-du-Var, 06700
    France

    Active - Recruiting

  • Clinique Pasteur

    Toulouse, 31300
    France

    Active - Recruiting

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