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8,000-Patient registry aims to sharpen carotid stenting safety

NCT ID NCT02240862

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This registry will follow 8,000 people with severe carotid artery disease who receive a stent to open the blocked artery. The main goal is to track how many have a stroke or die within 30 days of the procedure. The results will help select skilled doctors for a larger randomized trial comparing stenting to surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carotid artery stent (a mesh tube placed in the neck artery to keep it open)
What this could lead to
If successful, this registry could help identify the best doctors and techniques for carotid stenting, potentially improving stroke prevention in future patients.
What could go wrong
This is an observational registry, not a treatment trial, so it won't directly test if stenting works better than other options. Risks include stroke or death from the procedure itself.

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.

Participants

About 8,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2015

Expected to finish

Jan 2027

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.

Who is studied

Patients aged 18 - 80 years old with symptomatic or asymptomatic carotid artery disease.

Ages

18 to 80 years

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 Asymptomatic patients: Age ≥ 18 and ≤ 80 and any one of the following 1. ≥70% stenosis, standard surgical risk for CEA 2. ≥70% stenosis, high anatomic risk for CEA 3. ≥70% stenosis, high physiologic risk for CEA Symptomatic patients: Symptomatic patients are defined by the following characteristics: Ipsilateral carotid Transient Ischemic Attack (TIA), with neurologic symptoms persisting less than 24 hours; Ipsilateral non-disabling stroke: Modified Rankin Scale (mRS) ≤ 3; and Ipsilateral transient monocular blindness: amaurosis fugax. \[Source: current Medicare NCD for CAS\] Age ≥ 18 and ≤ 80 and any one of the following 1. ≥50% stenosis, standard surgical risk for CEA 2. 50% to 69% stenosis, high anatomic risk for CEA 3. 50% to 69% stenosis, high physiologic risk 4. ≥70% stenosis, high anatomic and/or physiologic risk for CEA - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R 5. ≥70% stenosis, post-CEA and -CAS - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R 6. ≥70% stenosis, post-irradiation - currently covered by Medicare, but sites are strongly encouraged to voluntarily include these patients in C2R Exclusion Criteria: Patients with any one of the following conditions are ineligible for enrollment in C2R 1. NYHA Class IV CHF 2. COPD on chronic continuous oxygen therapy 3. Severe (Class Childs D) liver failure 4. End-stage renal failure requiring dialysis 5. Cancer with metastatic spread and/or undergoing active chemotherapeutic treatment 6. Any dementia considered greater than "mild"

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Conditions

The condition(s) this trial relates to.

carotid artery disorder carotid stenosis

As listed by the trial registrant

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

Carotid artery diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Maryland - Administrative Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

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