Non-invasive detection of coronary stent complications using a new device

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

The NIMBLE-I study is a pilot clinical trial evaluating the feasibility and safety of a novel non-invasive device called the NIMBLE system for detecting complications related to coronary stents, particularly in-stent restenosis. Conducted at the Hospital Germans Trias i Pujol in Spain, this single-center trial aims to provide a safer alternative to traditional invasive diagnostic methods. The NIMBLE system utilizes microwave interferometry to monitor changes in the stent environment without the need for ionizing radiation or invasive procedures. The study will assess the usability and preliminary performance of this innovative approach in patients scheduled for coronary angiography.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Prior implantation of one or more coronary stents
* Clinical symptoms suggestive of stent failure (e.g., chest pain, ischemic ECG changes)
* Undergoing scheduled coronary angiography
* Informed consent provided

Exclusion Criteria:

* Pregnancy
* Implanted electronic devices (e.g., pacemakers) that may interfere with MWI
* Inability to provide consent
* Chest conditions preventing correct positioning of the device

Where it's running

• Hospital Universitari Germans Trias i Pujol
  Badalona, Catalonia, Spain Recruiting

Study contacts

• Principal investigator: Oriol Rodriguez-Leor, MD, PhD — Germans Trias i Pujol Hospital

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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.