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New Large-Vessel heart stent tested in Real-World patients

NCT ID NCT05423379

Disease control Sponsor: Abbott Medical Devices 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a special stent (a small mesh tube) coated with the drug everolimus, designed for large coronary arteries. It involves 102 people with coronary artery disease who need a stent. The goal is to see how safe and effective the stent is in everyday medical practice, tracking events like heart attacks or the need for repeat procedures.

What this could mean

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

Active substance
everolimus-eluting coronary stent
What this could lead to
If successful, this could confirm that the larger stent is a safe and effective option for treating blocked large coronary arteries, expanding treatment choices.
What could go wrong
This is an observational study without a comparison group, so results may not prove superiority over other stents. Risks include typical stent complications like blood clots or re-narrowing.

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

102 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Subjects of all genders from the general population who have at least one XIENCE Skypoint LV implanted.

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: General Inclusion Criteria 1. Subject must be at least 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent per site requirements. 3. Subject must have evidence of myocardial ischemia (STEMI, NSTEMI, Unstable Angina or Stable Angina) or who have silent ischemia with evidence of ischemia, appropriate for PCI treatment with DES. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following: 1. Abnormal stress or imaging stress test 2. Abnormal computed tomography-fractional flow reserve (CT-FFR) 3. Stenosis by visual estimation ≥ 70% 4. Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio \[iFR\], or relative flow reserve \[RFR\]) 4. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure. Angiographic Inclusion Criteria 1. Patients who have lesion(s) in a vessel with reference vessel diameter \> 4.25 mm and ≤ 5.25 mm as the target lesion 2. Patients who receive at least one Skypoint LV stent 1. Lesions with RVD ≤ 4.25 mm should be treated as the non-target lesions during the index procedure with commercially available XIENCE family of stents 2. Up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure. Exclusion Criteria: General Exclusion Criteria 1. Patients who have contraindications of the Skypoint LV per the IFU 2. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months. Angiographic Exclusion Criteria: 1. Patients who require three vessel treatment. 2. If left main coronary artery (LMCA) is the intended target vessel, patients who have unprotected left main disease with the SYNTAX Score ≥ 23 1. Unprotected LM disease with a SYNTAX score ≤ 22 (site-assessment) can be treated as the target lesion but not to exceed 40% of the study population 2. A heart team consensus approach per site's standard of care (SOC) to enhance patient protection and optimal clinical practice for the left main treatment is required.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

Contacts and locations

Locations

  • Anmed Health

    Anderson, South Carolina, 29621, United States

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Austin Heart

    Austin, Texas, 78756, United States

  • Bryan Heart

    Lincoln, Nebraska, 68506, United States

  • Clinique Pasteur Toulouse

    Toulouse, Midi-Pyrenees, 31300, France

  • Greenville Health System

    Greenville, South Carolina, 29605-5601, United States

  • Hendrick Medical Center

    Abilene, Texas, 79601, United States

  • Hopital Cardiovasculaire et Pneumologique Louis Pradel

    Lyon, Rhone, France

  • Hospital Clinico San Carlos

    Madrid, Madrid, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Spain

  • Hospital Virgen de Rocio

    Seville, Spain

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Memorial Hospital Jacksonville

    Jacksonville, Florida, 32216, United States

  • Pinnacle Health System

    Wormleysburg, Pennsylvania, 17043, United States

  • Shannon Clinic

    San Angelo, Texas, 76903, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75074, United States

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas, 67226, United States

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