Non-invasive detection of coronary stent complications using a new device
First-in-human Study to Assess the Clinical Feasibility, Safety, and Performance of the α Prototype of the NIMBLE System for Diagnosing Complications in Intracoronary Stents. NIMBLE-I Study.
This study is testing a new non-invasive device to see if it can safely detect problems with coronary stents in patients who need heart tests.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nimble Diagnostics S.L. Industry-sponsored |
| Locations | 1 site (Badalona, Catalonia) |
| Trial ID | NCT06968858 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients who have had one or more coronary stents implanted and are experiencing symptoms suggestive of stent failure.
Not a fit: Patients with implanted electronic devices like pacemakers or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce the need for invasive procedures in monitoring coronary stent complications, improving patient safety and comfort.
How similar studies have performed: While the approach of using non-invasive monitoring for stent complications is innovative, similar studies have shown promise in other non-invasive diagnostic technologies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Badalona, Catalonia
- Hospital Universitari Germans Trias i Pujol — Badalona, Catalonia, Spain (Recruiting)
Study contacts
- Principal investigator: Oriol Rodriguez-Leor, MD, PhD — Germans Trias i Pujol Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.