Recruiting PHASE1, PHASE2 In-stent Restenosis

Tests treatment safety and results for In-stent Restenosis

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

ClinicalTrials.gov ID: NCT06968858

What this study is testing

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • This is a blinded study.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join if

  • 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

You likely can't join if

  • Pregnancy
  • Implanted electronic devices (e.g., pacemakers) that may interfere with MWI
  • Inability to provide consent
  • Chest conditions preventing correct positioning of the device

The study team makes the final eligibility decision.

Where it's taking place

  • Badalona, Catalonia, Spain

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Badalona, Catalonia, Spain. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.