Evaluating safety and effectiveness of a procedure for heavily calcified coronary lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational multicenter cohort study aims to evaluate the safety and effectiveness of rotational atherectomy in patients with calcified coronary lesions undergoing percutaneous coronary intervention (PCI). Participants will provide informed consent for data collection, which will include demographics, clinical data, and follow-up results. The study will aggregate data from multiple centers across Asia to assess procedural outcomes and complications associated with this treatment approach. The findings will help to understand the representativeness of the data collected and the effectiveness of rotational atherectomy in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to understand and sign an informed consent form
* Presence of clinical indication for percutaneous coronary intervention (PCI) and/or stent placement
* Subjects willing to comply with all research and follow-up requirements.
* Angiographic criteria (ONE of the following criteria MUST be met)

  1. Target lesions visually have at least moderate calcifications\*
  2. Target lesion balloon dilatation failure
  3. Inability of devices (microcatheters, balloons or stents) to pass through the target lesion.
* Procedural criteria

  1. All patients treated with RA with or without other forms of debulking therapy

     * Moderate calcification is defined as radio-opacities noted only during cardiac cycle prior to contrast injection whereas severe calcification is defined as radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen.

Exclusion Criteria:

* Decline to give consent

Where it's running

• Kokura Memorial hospital
  Kitakyushu, Japan Recruiting
• National Heart Centre Singapore
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Khung Keong Yeo — Singhealth Foundation
• Study coordinator: James Low
• Email: james.low.j.y@nhcs.com.sg
• Phone: 67042280

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two methods for treating severely calcified coronary lesions

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• Registry to evaluate outcomes of coronary artery disease patients treated with specific balloon catheters

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  Recruiting Luzerner Kantonsspital · Lucerne, Canton of Lucerne · NCT04988685

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.