- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05301218
CAlcified Lesion Intervention Planning Steered by OCT. (CALIPSO)
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Nicolas Amabile, MD PhD
- Telefonní číslo: 33 0156616983
- E-mail: nicolas.amabile@imm.fr
Studijní záloha kontaktů
- Jméno: Silvia Burbassi, PhD
- Telefonní číslo: 33 0156616983
- E-mail: silvia.burbassi@imm.fr
Studijní místa
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Bastia, Francie, 20600
- Nábor
- CH de Bastia
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Kontakt:
- Ziad Boueri, MD
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Besançon, Francie, 25000
- Nábor
- CHU de Besancon
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Kontakt:
- Nicolas Meneveau, MD
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Bordeaux, Francie, 33000
- Nábor
- CHU de Bordeaux
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Kontakt:
- Benjamin Séguy, MD
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Bordeaux, Francie, 33200
- Nábor
- Clinique Saint Augustin
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Kontakt:
- Frederic Casassus, MD
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Clermont-Ferrand, Francie, 63000
- Nábor
- CHU de Clermont-Ferrand
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Kontakt:
- Géraud SOUTEYRAND, MD
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Le Coudray, Francie, 28630
- Nábor
- Hôpital Louis Pasteur
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Kontakt:
- Grégoire RANGé Rangé, MD
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Nantes, Francie, 44000
- Nábor
- L'Hôpital privé du Confluent
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Kontakt:
- Erwan BRESSOLLETTE, MD
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Nîmes, Francie, 30029
- Nábor
- Chu Nimes
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Kontakt:
- Guillaume Cayla, MD
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Ollioules, Francie, 83190
- Nábor
- Polyclinique Les Fleurs
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Kontakt:
- Philippe Commeau, MD
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Poitiers, Francie, 86000
- Nábor
- CHU de Poitiers
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Kontakt:
- Sébastien Levesque, MD
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Rouen, Francie, 76000
- Nábor
- Clinique Saint-Hilaire
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Kontakt:
- Quentin LANDOLFF, MD
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Saint-Laurent-du-Var, Francie, 06700
- Nábor
- Institut Arnaud Tzanck,
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Kontakt:
- Julien ADJEDJ, MD
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Toulouse, Francie, 31300
- Nábor
- Clinique PASTEUR
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Kontakt:
- Benjamin HONTON, MD
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Ile De France
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Paris, Ile De France, Francie, 75014
- Nábor
- Institut Mutualiste Montsouris
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Kontakt:
- Silvia Burbassi, PhD
- Telefonní číslo: 33 0156616983
- E-mail: silvia.burbassi@imm.fr
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Vrchní vyšetřovatel:
- Nicolas Amabile, MD PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Patient with chronic coronary syndrome
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)
- Possibility to cross the target lesion with OCT catheter
Exclusion Criteria:
- On-going cardiogenic shock
- Acute coronary syndrome related to target lesion
- Severe renal failure (Creatinine clearance: 30 ml/min/m2)
- Impossibility to cross target lesion with OCT catheter & balloons,
- Indication for Rotablator device as first line therapy
- Pregnancy
- Age < 18 y
- Denial to provide consent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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.
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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
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Experimentální: 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.
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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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
The primary endpoint of the CALIPSO study is the minimal stent area (MSA) on the final OCT run
Časové okno: During the procedure
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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).
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During the procedure
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Geometrical stent expansion (%) according to the DOCTORS or LEMON criteria
Časové okno: during procedure
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After the stent is deployed, the blood flow dynamics influence the mechanics by compressing and expanding the structure.
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during procedure
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Residual post PCI (Percutaneous Coronary Intervention)stenosis (assessed by QCA methods)
Časové okno: during procedure
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Qualitative Comparative Analysis (QCA) is a methodology that enables the analysis of multiple cases in complex situations
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during procedure
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Residual major struts malapposition: crude incidence and quantification
Časové okno: during procedure
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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.
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during procedure
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Major adverse cardiovascular events at 30 days and 1 year
Časové okno: at 30 days and 1 year
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Cardiovascular death + Any myocardial infarction + need for re-intervention on the target lesion (TLR)
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at 30 days and 1 year
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Peri-procedural MI according to the SCAI definition (23)
Časové okno: during procedure
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according to the SCAI definition (Moussa et al., Journal of the American College of Cardiology 2013)
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during procedure
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Coronary artery perforation: incidence
Časové okno: during the procedure and During the full participation period (1 year).]
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Coronary perforation was defined as evidence of extravasation of dye or blood from the coronary artery during or following the interventional procedure
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during the procedure and During the full participation period (1 year).]
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Radiation dose
Časové okno: during procedure
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Differences in dose radiation used during le procedure
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during procedure
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Total Contrast medium volume
Časové okno: during procedure
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Differences in amount of contrast drug used during le procedure
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during procedure
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Procedure duration
Časové okno: 24th post-operative hour
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differences in duration (time) of the procedure
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24th post-operative hour
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Nicolas Amabile, MD PhD, Institut Mutualiste Montsouris
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CARDIO 04 2021
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