First-in-human Study to Assess the Clinical Feasibility, Safety, and Performance of the b1 Prototype of the NIMBLE System for Diagnosing Complications in Intracoronary Stents. NIMBLE-I Study.

What this Trial Is About

Researchers are evaluating a new medical device called the NIMBLE system designed for non-invasive monitoring of coronary stents in adults who have previously received stent implants. This pilot clinical trial aims to assess the technical feasibility and safety of the NIMBLE prototype, which uses microwave interferometry to detect in-stent restenosis (ISR), a common complication affecting up to 10% of patients after stent placement. The study is conducted at a single center in Spain under expert supervision and sponsored by Nimble Diagnostics. During the study, participants undergo a non-invasive NIMBLE scan performed externally on the chest before their scheduled coronary angiography. The device uses biocompatible transducers placed over the stent location to collect data without disrupting routine care. Up to 120 patients will be enrolled, with 30 undergoing additional OCT imaging to compare device measurements. After the NIMBLE assessment, patients proceed with standard invasive angiography, and the angiography team remains unaware of NIMBLE results to ensure unbiased comparison. Participants will provide informed consent and undergo the NIMBLE scan shortly before their angiography. Researchers will monitor for any device-related adverse events up to seven days after the test. The primary outcomes focus on successful data acquisition and safety, while secondary outcomes evaluate diagnostic performance by comparing NIMBLE results with invasive imaging and usability feedback from clinicians and patients. Data confidentiality and ethical guidelines are strictly followed throughout the study, which continues until October 2025.

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