CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement. (CORONATE)

August 12, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Aortic valve stenosis is the most frequent heart valve disease in the adult population. The development of biological prostheses with slower valve degeneration and easier antithrombotic management and changes in the indications for the treatment of this valve disease, have allowed a reduction in the age in which such prostheses are implanted thus leading to a greater use of biological prostheses rather than mechanical ones. In the next few years this will cause a higher rate of structural valve degeneration resulting in stenosis and/or insufficiency. In patients considered to be at high surgical risk, the transcatheter implantation of a valve-in-valve (VIV) represents a valid alternative to standard surgery, except for coronary obstruction which appears more frequent in VIV procedures, especially in patients receiving VIV after surgical aortic valve replacement. The risk factors mainly associated with this complication are represented by the type of implanted prostheses and the anatomical relationship between the coronary ostia and the expected final position of the cusps of the bioprostheses transcatheter-implanted.Recent studies have demonstrated how coronary height seems to be significantly reduced in case of surgical aortic valve replacement with a supra-annular technique, as occurs in our center.

Aim of this interventional, single-center study is to demonstrate whether there is a change in the coronary ostia height after surgical aortic valve replacement and whether it possibly depends on the type of prosthesis.

All patients undergoing elective aortic valve replacement surgery at our institution who meet the inclusion criteria for the study will be contacted to perform a postoperative CT scan at least 90 days after surgery.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Policlinico Agostino Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis;
  • Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization;
  • CT imaging of the thorax with iodinated contrast agent carried out before surgery;
  • Signed informed consent, inclusive of release of medical information.

Exclusion Criteria:

  • Aortic valve replacement in bicuspid valve or endocarditis;
  • Aortic valve replacement associated with surgery of ascending aorta/aortic root;
  • Aortic valve replacement associated with other cardiac valve surgery;
  • Previous cardiac surgery of any kind;
  • Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator;
  • Participation in another clinical trial that could interfere with the endpoints of this study;
  • Pregnant at time of screening;
  • Allergy or hypersensitivity to iodinated contrast agent;
  • End-stage renal disease on dialysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical Aortic Valve Replacement
Patients undergoing surgical aortic valve replacement with a bioprosthesis will be asked to perform a thorax CT scan before surgery and one more at least 90 days after surgery.
Radiation: CT scan with contrast medium
Multi-detector CT scan (if possible with prospective-ECG gated sequential scan) with contrast medium injection of nonionic contrast agent. All CT datasets will be analysed for the qualitative and quantitative assessment of the aortic root. The coronary height will be assessed at baseline in relation to the aortic annulus and in relation to the stent of the bioprostheses after aortic valve replacement.
Other Names:
  • CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary ostia height differences.
Time Frame: At least 90 days after surgery
Differences in coronary ostia height before and after surgical aortic valve replacement.
At least 90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary ostia height differences between different bioprostheses.
Time Frame: At least 90 days after surgery
Differences in coronary ostia height before and after surgical aortic valve replacement according to different bioprostheses used.
At least 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Massimo Massetti, MD, Policlinico Agostino Gemelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2023

Primary Completion (Estimated)

November 10, 2025

Study Completion (Estimated)

January 10, 2026

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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