Calcium Reduction by Orbital Atherectomy in Western Europe: the CROWN study

• Conditions: Calcified coronary lesions; 10011082

• Registration Number: NL-OMON51361
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1. De novo significant native coronary artery lesion.
2. The target lesion must have evidence of severe calcification:
a. 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.
b. Presence of >=270° of calcium or lumen protruding calcified nodule(s) at >1
cross section assessed by OCT.
3. The target vessel reference diameter >= 2.5 mm and <= 4.0 mm and lesion must
not exceed 40 mm in length.
4. Age > 18 years or minimum age as required by local regulations

Exclusion Criteria

1. Left main disease
2. Prior stenting of the target vessel.
3. Target lesion has thrombus or dissection.
4. Known LVEF <=25%.
5. Diagnosed with chronic renal failure (GFR<30ml/min)
6. Confirmed pregnancy.
7. Life expectancy <12months.
8. Age<18y.
9. Coronary anatomy that prevent delivery of OCT catheter
10. Known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium
hydroxide

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is proportion of patients with stent<br /><br>expansion defined by OCT derived minimal stent area (MSA) >= 5.5mm².</p><br>