Status:
RECRUITING
Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis
Lead Sponsor:
Nimble Diagnostics S.L.
Conditions:
In-stent Restenosis
Stent Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 bei...
Detailed Description
The NIMBLE-I study is a prospective, single-center, single-arm pilot clinical trial designed to assess the feasibility, safety, usability, and preliminary diagnostic performance of the NIMBLE prototyp...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Implanted electronic devices (e.g., pacemakers) that may interfere with MWI
- Inability to provide consent
- Chest conditions preventing correct positioning of the device
Key Trial Info
Start Date :
September 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06968858
Start Date
September 12 2024
End Date
October 1 2025
Last Update
May 13 2025
Active Locations (1)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain, 08916