CT scans could make heart stent surgery safer and faster
NCT ID NCT07286578
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 7 times
Summary
This study tests whether using a CT scan to guide heart stent placement is better than the current standard (IVUS ultrasound) for people with hardened, calcified coronary arteries. About 700 adults with evidence of reduced blood flow to the heart will be randomly assigned to one of the two imaging methods. The goal is to see if CT guidance leads to better stent expansion and similar or fewer heart problems over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CT-guided percutaneous coronary intervention (stent placement) compared to IVUS-guided percutaneous coronary intervention
- What this could lead to
- If successful, CT guidance could make heart stent procedures faster and more effective for patients with calcified arteries, potentially reducing complications.
- What could go wrong
- This is a mid-stage trial with 700 participants, so results may not apply to all patients. CT guidance might not improve outcomes or could have unforeseen risks.
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
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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.
- Participants
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About 700 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * The subject must be at least 18 years of age and younger than 85 years old * Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression\>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score\>140. * All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm * Subject must provide written informed consent before any study-related procedure Exclusion Criteria: * STEMI as the clinical presentation. * Uncontrolled or recurrent ventricular tachycardia. * Hemodynamic instability. * Hemodialysis or peritoneal dialysis. * Left main coronary artery stenosis \> 50% * Atrial fibrillation, flutter, or arrhythmias during CT acquisition. * Previous PCI in the target vessel or CABG. * BMI ≥ 40 kg/m2 * Insufficient CT quality assessed by the Core lab. * Comorbidity with life expectancy ≤ 2 years. * Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded. * The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months. * The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy. * The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum. * Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3. * The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B. * The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy \<2 years for any non-cardiac cause. * Subject is currently participating in another investigational drug or device clinical study. * Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. * Unable to provide written informed consent (IC).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
14 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Azorg Hospital, Aalst
RECRUITINGAalst, 9300, Belgium
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Bringham and Women's Hospital
NOT_YET_RECRUITINGBoston, Massachusetts, 02115, United States
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Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
NOT_YET_RECRUITINGNew York, New York, 10032, United States
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HACKENSACK MERIDIAN HEALTH, Inc
NOT_YET_RECRUITINGJersey City, New Jersey, 08837, United States
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Hospital Universitari Vall Hebron
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitario La Paz
RECRUITINGMadrid, 28046, Spain
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Hospital Universitario de Leon
RECRUITINGLeón, Spain
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John Radcliffe Hospital, Oxford
NOT_YET_RECRUITINGOxford, United Kingdom
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Minneapolis Heart Institute
RECRUITINGMinneapolis, Minnesota, 55407, United States
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Newcastle Hospitals NHS Foundations Trust
NOT_YET_RECRUITINGNewcastle, United Kingdom
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St Bartholomew's Hospital (Barts Health NHS Trust)
RECRUITINGLondon, United Kingdom
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St George's University Hospitals NHS Foundations Trust
RECRUITINGLondon, United Kingdom
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University Hospitals of Leicester NHS Trust
RECRUITINGLeicester, United Kingdom
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Weill Medical College of Cornell University
NOT_YET_RECRUITINGNew York, New York, 14853, United States
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Other studies related to the condition(s) this trial covers.
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