Status:
UNKNOWN
Calcium Reduction by Orbital Atherectomy in Western Europe
Lead Sponsor:
Erasmus Medical Center
Conditions:
Vascular Calcification* / Diagnostic Imaging
Atherectomies, Coronary
Eligibility:
All Genders
18+ years
Brief Summary
In calcified lesions, optimal stent placement and expansion may prove to be challenging. Lesion preparation is necessary to facilitate optimal stenting in calcified lesions, for which orbital atherect...
Detailed Description
The Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems Inc., St. Paul,MN,USA) is a percutaneous device indicated to modify calcified lesion in order to facilitate stent...
Eligibility Criteria
Inclusion
- De novo significant native coronary artery lesion
- The target lesion must have evidence of severe calcification: 1) presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall with calcification length of at least 15 mm and extend partially into the target lesion. 2) OR presence of ≥ 270° of calcium or lumen protruding calcified nodules at \>1 cross section by intravascular imaging (OCT)
- The target vessel reference diameter ≥ 2.5 mm and ≤ 4.0 mm and lesion must not exceed 40 mm in length
Exclusion
- Left main disease
- Prior stenting of the target vessel
- Target lesion has thrombus or dissection
- Known left ventricular ejection fraction LVEF ≤ 25%
- Diagnosed with chronic renal failure (GFR \< 30 ml/min)
- Confirmed pregnancy
- Life expectancy \< 12 months
- Coronary anatomy that prevents delivery of OCT catheter
- Known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide
Key Trial Info
Start Date :
March 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06035783
Start Date
March 15 2024
End Date
April 1 2025
Last Update
February 29 2024
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GE