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Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllNimble Diagnostics S.L.
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In plain words

What the trial is, and whether it could suit you

The NIMBLE-I study is a prospective, unicentric, single arm, feasibility clinical trial designed to evaluate a novel medical device for the non-invasive monitoring of coronary stents. The study is being conducted at the Hospital Germans Trias i Pujol in Badalona, Spain, under the supervision of Dr. Oriol Rodríguez Leor, an experienced interventional cardiologist. It is sponsored by NIMBLE Diagnostics, a company developing the NIMBLE system-a non-ionizing, non-invasive prototype based on microwave interferometry (MWI). The motivation behind the study stems from the clinical challenge of detecting in-stent restenosis (ISR), a common complication following stent implantation that affects up to 10% of patients. Current diagnostic methods typically rely on invasive procedures such as coronary angiography or intravascular imaging, which are resource-intensive and carry procedural risks. The N

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • NIMBLE test
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Where

1 site
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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