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CAlcified Lesion Intervention Planning Steered by OCT. (CALIPSO)

14. november 2022 oppdatert av: Institut Mutualiste Montsouris

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

140

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
      • Bastia, Frankrike, 20600
        • Rekruttering
        • CH de Bastia
        • Ta kontakt med:
          • Ziad Boueri, MD
      • Besançon, Frankrike, 25000
        • Rekruttering
        • CHU de Besancon
        • Ta kontakt med:
          • Nicolas Meneveau, MD
      • Bordeaux, Frankrike, 33000
        • Rekruttering
        • CHU de Bordeaux
        • Ta kontakt med:
          • Benjamin Séguy, MD
      • Bordeaux, Frankrike, 33200
        • Rekruttering
        • Clinique Saint Augustin
        • Ta kontakt med:
          • Frederic Casassus, MD
      • Clermont-Ferrand, Frankrike, 63000
        • Rekruttering
        • CHU de Clermont-Ferrand
        • Ta kontakt med:
          • Géraud SOUTEYRAND, MD
      • Le Coudray, Frankrike, 28630
        • Rekruttering
        • Hôpital Louis Pasteur
        • Ta kontakt med:
          • Grégoire RANGé Rangé, MD
      • Nantes, Frankrike, 44000
        • Rekruttering
        • L'Hôpital privé du Confluent
        • Ta kontakt med:
          • Erwan BRESSOLLETTE, MD
      • Nîmes, Frankrike, 30029
        • Rekruttering
        • Chu Nimes
        • Ta kontakt med:
          • Guillaume Cayla, MD
      • Ollioules, Frankrike, 83190
        • Rekruttering
        • Polyclinique Les Fleurs
        • Ta kontakt med:
          • Philippe Commeau, MD
      • Poitiers, Frankrike, 86000
        • Rekruttering
        • CHU de Poitiers
        • Ta kontakt med:
          • Sébastien Levesque, MD
      • Rouen, Frankrike, 76000
        • Rekruttering
        • Clinique Saint-Hilaire
        • Ta kontakt med:
          • Quentin LANDOLFF, MD
      • Saint-Laurent-du-Var, Frankrike, 06700
        • Rekruttering
        • Institut Arnaud Tzanck,
        • Ta kontakt med:
          • Julien ADJEDJ, MD
      • Toulouse, Frankrike, 31300
        • Rekruttering
        • Clinique PASTEUR
        • Ta kontakt med:
          • Benjamin HONTON, MD
    • Ile De France
      • Paris, Ile De France, Frankrike, 75014
        • Rekruttering
        • Institut Mutualiste Montsouris
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nicolas Amabile, MD PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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 before contrast dye injection (Aksoy et al., Circ Cardiovasc Interv 2019)
    • Severe: lesion with radio-opacities seen without cardiac motion before contrast dye injection, visible on both sides of the arterial lumen(Aksoy et al., Circ Cardiovasc Interv 2019)
  3. Possibility to cross the target lesion with OCT catheter

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: angiography-guided group
the treatment (including lesion preparation, stent sizing and post implantation optimization) will be performed by angiography. Once the result is considered optimal by the operator, a control OCT run will be acquired.
Fremgangsmåte: angioplasty
Coronary angioplasty, also called percutaneous coronary intervention, is a procedure used to open clogged heart arteries. Angioplasty uses a tiny balloon catheter that is inserted in a blocked blood vessel to help widen it and improve blood flow to the heart
Eksperimentell: OCT-guided group
a preliminary OCT run will be recorded. An initial predilation with 1.5 to 2.0 mm balloon could be accepted in order to facilitate OCT catheter delivery through the target lesion. The PCI strategy will be guided by a pre-defined algorithm based on initial OCT findings. Post PCI result will be assessed by control OCT and potential optimization steps could be applied according to the results. The MLD-MAX optimization approach will be applied. Final OCT run will be performed at the end of the procedure.
Fremgangsmåte: angioplasty
Coronary angioplasty, also called percutaneous coronary intervention, is a procedure used to open clogged heart arteries. Angioplasty uses a tiny balloon catheter that is inserted in a blocked blood vessel to help widen it and improve blood flow to the heart

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run
Tidsramme: During the procedure
The crude minimal stent area (MSA) will be measured along the stent on the target lesion. Stent geometric expansion will be evaluated by the DOCTORS criteria for non-bifurcated segments (Meneveau et, Circulation 2016) and LEMON criteria for bifurcated segments (Amabile et al;, Eurointervention 2020).
During the procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria
Tidsramme: during procedure
After the stent is deployed, the blood flow dynamics influence the mechanics by compressing and expanding the structure.
during procedure
Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods)
Tidsramme: during procedure
Qualitative Comparative Analysis (QCA) is a methodology that enables the analysis of multiple cases in complex situations
during procedure
Residual major struts malapposition: crude incidence and quantification
Tidsramme: during procedure
malapposition was defined as a lack of contact of at least 1 strut with the underlying vessel wall (at least 150 μm, in the absence of a side branch) with evidence of blood flow behind the strut. It was classified as "major" malapposition if there was evidence of at least 30% of the struts in one frame.
during procedure
Major adverse cardiovascular events at 30 days and 1 year
Tidsramme: at 30 days and 1 year
Cardiovascular death + Any myocardial infarction + need for re-intervention on the target lesion (TLR)
at 30 days and 1 year
Peri-procedural MI according to the SCAI definition (23)
Tidsramme: during procedure
according to the SCAI definition (Moussa et al., Journal of the American College of Cardiology 2013)
during procedure
Coronary artery perforation: incidence
Tidsramme: during the procedure and During the full participation period (1 year).]
Coronary perforation was defined as evidence of extravasation of dye or blood from the coronary artery during or following the interventional procedure
during the procedure and During the full participation period (1 year).]
Radiation dose
Tidsramme: during procedure
Differences in dose radiation used during le procedure
during procedure
Total Contrast medium volume
Tidsramme: during procedure
Differences in amount of contrast drug used during le procedure
during procedure
Procedure duration
Tidsramme: 24th post-operative hour
differences in duration (time) of the procedure
24th post-operative hour

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut Mutualiste Montsouris

Samarbeidspartnere

Abbott

Etterforskere

  • Hovedetterforsker: Nicolas Amabile, MD PhD, Institut Mutualiste Montsouris

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. desember 2021

Primær fullføring (Forventet)

15. desember 2023

Studiet fullført (Forventet)

15. desember 2023

Datoer for studieregistrering

Først innsendt

8. mars 2022

Først innsendt som oppfylte QC-kriteriene

17. mars 2022

Først lagt ut (Faktiske)

29. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. november 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. november 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CARDIO 04 2021

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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