Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease

Inclusive Invasive Physiological Assessment in Angina Syndromes - Obstructive Coronary Artery Disease

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stable Angina Pectoris; Coronary Artery Disease (CAD); Coronary Microvascular Dysfunction (CMD); Vasospasm, Coronary; Obstructive Coronary Artery Disease
• Intervention / Treatment: Procedure: Percutaneous coronary intervention; Diagnostic test: Coronary function testing

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous coronary intervention; Standard care arm, in which participants will receive their percutaneous coronary intervention (PCI) according to local practice standards and guidelines	Procedure: Percutaneous coronary intervention; Percutaneous coronary intervention performed according to local practice standards and guidelines; Other Names: PCI
Experimental: Percutaneous coronary intervention + coronary function testing; In the intervention group, participants will receive coronary function testing (CFT) before and after their percutaneous coronary intervention to test for coronary microvascular dysfunction and coronary vasospasm	Procedure: Percutaneous coronary intervention; Percutaneous coronary intervention performed according to local practice standards and guidelines; Other Names: PCI; Diagnostic test: Coronary function testing; Coronary function testing to test for coronary microvascular dysfunction and coronary vasospasm; Other Names: CFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angina symptom burden	The difference in the change in angina symptom score between groups from baseline to 6-month follow-up. Patients will keep track of their symptoms daily during which they can answer the question if they had symptoms with 'yes' or 'no'. If 'yes' is selected, they can select how frequent their attacks were on that day (from 0-10, were 0 = no attack and 10 = 10 or more attacks) and also the severity of the attacks (mild, moderate or severe). A higher score means a worse outcome.	From baseline to 6 months of follow-up (after procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference Seattle Angina Questionnaire Summary Score (SAQSS)	The mean difference in the within-subject change in Seattle Angina Questionnaire Summary Score (SAQSS) between the groups from baseline to 6-month follow-up. The score ranges from 0-100, where a higher score means a better outcome.	From baseline to 6 months of follow-up (after procedure)
Difference Canadian Cardiovascular Society (CCS) grading of angina pectoris	Between-group difference in angina severity as assessed by the Canadian Cardiovascular Society class at 6-month follow-up and its change from baseline to 6-month follow-up. There are four classes: I, II, III and IV. A higher class means a higher angina/symptom burden (worse outcome).	From baseline to 6 months of follow-up (after procedure)
Difference Seattle Angina Questionnaire (SAQ)	Between-group difference in physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire (SAQ) at 6-month follow-up, and their change from baseline to 6-month follow-up. The subscales are all transformed to a scale from 0-100, where a higher score means a better outcome.	From baseline to 6 months of follow-up (after procedure)
Difference EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L)	Between-group difference in quality of life as assessed with the EQ-5D-5L quality of life questionnaire at 6-month follow-up, and their change from baseline to 6-month follow-up. There are 5 domains with 5 levels, in which the scores are transformed to values ranging from -0,109 to 1,000. The EQ-5D-5L Visual Analog Scale (VAS) score, as part of the questionnaire, ranges from 0-100. In both cases a higher score means a better outcome.	From baseline to 6 months of follow-up (after procedure)
Difference Patient Global Impression of Change (PGI-C)	Patient Global Impression of Change (PGI-C) Score: at 6-, and 12-months post-procedure. The score ranges from 1-7, where a lower score means (better) improvement and higher scores means no improvement/worsening (worse outcome).	At 6 and 12 months of follow-up (after procedure)
Prevalence coronary vasomotor disorders	Prevalence of individual coronary vasomotor disorder endotypes in the intervention arm.	From baseline to 12 months of follow-up (after procedure)
Disease endotype	Impact of disease endotype on the between-group difference in clinical response to percutaneous coronary intervention.	From baseline to 12 months of follow-up (after procedure)
Role coronary computed tomography angiography (CCTA)	Relationship of coronary computed tomography angiography (CCTA) parameters (collected from patients from whom images are available) with hemodynamic relevance of coronary stenosis and the presence of coronary vasomotor disorders.	From baseline to 12 months of follow-up (after procedure)
Role of biomarkers	Relationship of biomarker levels and the presence of coronary vasomotor dysfunction.	From baseline to 12 months of follow-up (after procedure)
Adverse events	Adverse clinical events: Hospital admission for angina pectoris, acute coronary syndrome, unscheduled (repeat) coronary angiography, (cardiac) death.	From baseline to 12 months of follow-up (after procedure)
Similarity score	Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery, and during coronary function testing in the CFT-guided (intervention) arm, and its relationship with change in angina symptom score after revascularization. The similarity score ranges from 0-10, where 0 means patient has no (recognizable) complaints and 10 means patient experiences exactly the same pain as usual.	From baseline to 12 months of follow-up (after procedure)
Difference MacNew score	Between-group difference in quality of life as assessed with the MacNew quality of life questionnaire at 6-month follow-up. There are several items, which are scored from 1-7. Domain scores and global scores are calculated using the average scores of these items (so also from 1-7). A higher score means a better outcome.	From baseline to 6 months of follow-up (after procedure)
Canadian Cardiovascular Society (CCS) grading of angina pectoris at 12 months	Change in CCS class from 6-months to 12-months and from baseline to 12-months. There are four classes: I, II, III and IV. A higher class means a higher angina/symptom burden (worse outcome).	From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
Seattle Angina Questionnaire (SAQ) at 12 months	Change in SAQ from 6-months to 12-months and from baseline to 12-months. The subscales are all transformed to a scale from 0-100, where a higher score means a better outcome.	From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
Seattle Angina Questtionaire Summary Score (SAQSS) at 12 months	Change in SAQSS from 6-months to 12-months and from baseline to 12-months. The score ranges from 0-100, where a higher score means a better outcome.	From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L) at 12 months	Change in EQ-5D-5L from 6-months to 12-months and from baseline to 12-months. There are 5 domains with 5 levels, in which the scores are transformed to values ranging from -0,109 to 1,000. The EQ-5D-5L Visual Analog Scale (VAS) score, as part of the questionnaire, ranges from 0-100. In both cases a higher score means a better outcome.	From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)
MacNew at 12 months	Change in MacNew from 6-months to 12-months and from baseline to 12-months. There are several items, which are scored from 1-7. Domain scores and global scores are calculated using the average scores of these items (so also from 1-7). A higher score means a better outcome.	From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure)

Collaborators and Investigators

• Sponsor: UMC Utrecht

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stable Angina; Percutaneous Coronary Intervention; Coronary Function Testing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Chest Pain; Angina Pectoris; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coronary Artery Disease; Angina, Stable; Coronary Vasospasm; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Percutaneous Coronary Intervention
• Other Study ID Numbers: ILIAS OBSTRUCTIVE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No