Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease
450 participantsStarted 2026-05-01
Plain-language summary
The goal of this clinical trial is to test whether adding coronary function testing and starting targeted medical treatment for identified vasomotor disorders will also improve angina symptoms and quality of life in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention. The main question it aims to answer is:
Does performing coronary function testing in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention lead to better relieve of angina symptoms and improvement in quality of life?
Researchers will compare this group undergoing coronary function testing with a control group who will solely undergo percutaneous coronary intervention.
Participants will:
* Undergo percutaneous coronary intervention and coronary function testing in the intervention arm
* Undergo percutaneous coronary intervention in the control arm
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients \>18 years of age
* Hemodynamically relevant obstructive coronary artery disease (as assessed by pressure wire evaluation) in the left anterior descending coronary artery amenable to percutaneous coronary intervention at the discretion of the operator.
Exclusion Criteria:
* Prior coronary artery bypass graft surgery.
* Stenosis \>90% in the target vessel or a stenosis deemed unsafe for pressure wire instrumentation
* Known severe left ventricular dysfunction (left ventricular ejection fraction by any imaging modality)
* Severe valvular disease
* Renal impairment (estimated glomerular filtration rate \<30mL/min)
* Contra-indications for the use of adenosine or acetylcholine
* Expected inability to conform to the clinical follow-up
* Unable or unwilling to use the ORBITA-app
* Life expectancy of less than 12 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Angina symptom burden
Timeframe: From baseline to 6 months of follow-up (after procedure)