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

Launched by NIMBLE DIAGNOSTICS S.L. · May 5, 2025

Keywords

ClinConnect Summary

The NIMBLE-I study is a clinical trial investigating a new device called the NIMBLE system, which aims to safely and easily check for complications related to coronary stents, specifically a condition known as in-stent restenosis (ISR). ISR can occur in some patients after stents are placed in their arteries, and the current methods to detect it are often invasive and can carry risks. This study will be conducted at a hospital in Spain and is looking to enroll up to 120 patients who have had coronary stents implanted and are experiencing symptoms like chest pain. Eligible participants must also be scheduled for a routine procedure called coronary angiography.

If you join the study, you will undergo a non-invasive scan with the NIMBLE device before your angiography. This scan is simple and involves placing a device on your chest to collect information without interfering with your usual care. The main goal of the trial is to see if the NIMBLE device is safe and effective in detecting problems around the stent compared to standard imaging methods. This research could potentially lead to a new and safer way to monitor patients with stents, reducing the need for more invasive procedures in the future.

Gender

ALL

Eligibility criteria

• 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