Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: CT(Computed Tomography) guided Percutaneous Coronary Intervention for Cardiovascular Diseases

The OPTIMAL randomly assigned clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.

Official registry: https://clinicaltrials.gov/study/NCT07286578 · Fundación EPIC · enrollment listed as 700

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are CT(Computed Tomography) guided Percutaneous Coronary Intervention, or IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention. The registry lists allocation as randomized. The OPTIMAL randomly assigned clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.

They plan to enroll about 700 people at 15 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium

Interventions: CT(Computed Tomography) guided Percutaneous Coronary Intervention, IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention

Primary outcome (registry wording): Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 85 Years
  • The subject must be at least 18 years of age and younger than 85 years old
  • All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm

Public study contact (from the registry)

CAROLINA FOCELLA

001 917 753 6695

cfocella@crf.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

15 listed

+ 10 sites outside the US on the same record

FAQ about this NCT record

Is NCT07286578 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07286578?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07286578?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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