Using orbital atherectomy to improve stent placement in calcified coronary lesions
Calcium Reduction by Orbital Atherectomy in Western Europe
This study is testing whether a special procedure called orbital atherectomy can help doctors place stents more effectively in patients with severely calcified coronary arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, Zuid Holland) |
| Trial ID | NCT06035783 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of orbital atherectomy in preparing severely calcified coronary lesions for optimal stent placement. Patients with significant calcification will undergo optical coherence tomography (OCT) guided orbital atherectomy followed by stent placement. The study will collect detailed imaging data to understand the mechanics of lesion preparation and assess stent expansion based on OCT-derived minimal stent area. A total of 100 patients will be enrolled to provide insights into the calcium modifying effects of this technique.
Who should consider this trial
Good fit: Ideal candidates are patients with de novo significant native coronary artery lesions exhibiting severe calcification.
Not a fit: Patients with left main disease, prior stenting of the target vessel, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved stent placement and outcomes for patients with severely calcified coronary artery disease.
How similar studies have performed: While the use of orbital atherectomy is established, this specific approach and detailed imaging analysis is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Rotterdam, Zuid Holland
- Erasmus Medical Center — Rotterdam, Zuid Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.