NCT07724184

Brief Summary

The primary aim of this study is to evaluate changes in absolute coronary flow and pressure before and after percutaneous coronary intervention in calcified lesions. The secondary aim is to use a machine learning model to predict the outcome of the intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
46mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Mar 2025May 2030

Study Start

First participant enrolled

March 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2.2 years

First QC Date

August 20, 2025

Last Update Submit

July 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-PCI FFR

    FFR is measured after PCI is completed.

    Immediately after the procedure

Interventions

The pressure and flow data will be integrated in a machine learning model

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This a prospective clinical cohort study recruiting patients with stable coronary artery disease referred to invasive coronary angiography on clinical indication with angiographic calcium and eligible for PCI.

You may qualify if:

  • Age \> 18 years
  • Moderate (40-90 %) epicardial disease
  • Vessel suitable for PCI and intracoronary imaging
  • De novo-lesions

You may not qualify if:

  • eGFR \< 40ml/min
  • ACS \< 48 hours
  • Patient without ability to provide informed consent
  • Patient with left main stenosis
  • Indication for coronary artery bypass grafting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Pressure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Central Study Contacts

Ashkan Eftekhari, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2025

First Posted

July 23, 2026

Study Start

March 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2030

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations