UnknownNot Applicable

Calcium Reduction by Orbital Atherectomy in Western Europe

Netherlands100 participantsStarted 2024-03-15

Plain-language 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 atherectomy can used. Therefore the aim of this study is to: 1. Show that orbital atherectomy effectuates optimal stent expansion 2. Investigate the mechanics of lesion preparation when using orbital atherectomy Patients presenting with a significant and severely calcified lesion in need of orbital atherectomy will undergo optical coherence tomography guided orbital atherectomy and stent placement.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary imaging endpoint

Timeframe: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

Trial details

NCT IDNCT06035783

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Vascular Calcification* / Diagnostic Imaging trials