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Withdrawn study sought to predict which legs could be saved

NCT ID NCT06014242

Diagnosis Sponsor: Hackensack Meridian Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study was designed to see if measuring blood flow resistance in tiny leg vessels could predict whether a limb could be saved after artery-opening procedures in people with critical limb ischemia. It planned to enroll patients with severe leg artery disease and use a special measurement technique during angiography. However, the study was withdrawn before any participants were enrolled, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Chronic critical limb ischemia (Rutherford 4-6). * Age ≥18 years * Ability and willingness to sign the IRB approved Informed Consent form Exclusion Criteria: * Non-reconstructable chronic total occlusive disease of the proximal inflow vessels that would make flow reserve measurements impossible. * Non-salvageable lower extremity due to infection or overwhelming per-existing tissue loss (most critical Rutherford 6 patients). * Inability to understand the study or a history of non-compliance with medical advice; * History of any cognitive or mental health status that would interfere with study participation; * Currently enrolled in any pre-approval investigational study. * Female subjects who are pregnant or nursing or planning to become pregnant within the study period; * Known sensitivity to contrast media, which can't be adequately pre-medicated; * Expected life span less than 6 months. * Unable to read/understand/sign the English Language consent form

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease

More trials for these conditions

Other studies related to the condition(s) this trial covers.