Status:
UNKNOWN
CAlcified Lesion Intervention Planning Steered by OCT.
Lead Sponsor:
Institut Mutualiste Montsouris
Collaborating Sponsors:
Abbott
Conditions:
Coronary Artery Calcification
Angioplasty
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2023
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05301218
Start Date
December 15 2021
End Date
December 15 2023
Last Update
November 15 2022
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Ch de Bastia
Bastia, France, 20600
2
CHU de Besançon
Besançon, France, 25000
3
CHU de Bordeaux
Bordeaux, France, 33000
4
Clinique Saint Augustin
Bordeaux, France, 33200