Advanced Invasive Diagnosis Strategy for Post-PCI Patients With Stable Coronary Syndromes Undergoing Coronary Angiography

NCT07638137 | Recruiting DMC

• 1 other identifier: 22/193E
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 5

Brief Summary

AID Post-PCI Angina is as an observational, prospective, single-cohort, multicenter study designed to investigate the causes and origins of post-PCI angina by using the advance invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP) in an all-comers population of patients with post-PCI angina referred for invasive coronary angiography. An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI), who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography (ICA) will be enrolled. ICA will be performed with the application of the structure AID strategy to evaluate both obstructive and non-obstructive cause of myocardial ischemia. Then, angiography derived physiological assessment of epicardial coronary artery using functional coronary angiography in each vessel will be performed in both index procedure and the previous procedure in all patients. By combining information obtained from both procedures, the causes and origins of post-PCI angina will be made. Treatment will be decided by the operators according to the result. Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline and at 1, 6, and 12 months after the procedure. The main hypothesis of this study states that, in patients with post-PCI angina referred to ICA, the application of the structured AID strategy combining with angiography derived physiology (ADP) will lead to a high diagnostic yield in identifying the origins of obstructive disease and causes of post-PCI angina.

Conditions

INOCA (Ischemia With Non Obstructive Coronary Artery Disease); Angina (Stable); Percutaneous Coronary Intervention (PCI); Chronic Coronary Syndrome

Keywords

Angina; Percutaneous Coronary Intervention; Chronic Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• The proportion of patients in whom the origins of obstructive disease and causes of post-PCI angina is identified using the AID strategy combining with ADP.

  To establish the obstructive and non-obstructive causes of post-PCI angina and the origins of obstructive disease in an all-comers population of patients referred for invasive angiography using the AID strategy combining with ADP. The origins of obstructive disease can be classified as * Progression of CAD: the presence of a new hemodynamically significant stenosis outside the previous stent(s) which was not detectable by the previous angiogram (Previous PCI µFR\>0.80). * Post-PCI residual disease: the presence of a hemodynamically significant stenosis outside the stent(s) segment, which was detectable by the previous angiogram (Previous PCI µFR≤0.80). * Suboptimal stenting: the presence of a hemodynamically significant stenosis within the stented segment, which was detectable by the previous angiogram (Previous PCI µFR≤0.80). * In stent restenosis (ISR): the presence of a hemodynamically significant stenosis inside the stented segment which was not detectable by the previous angiogram

  Baseline.

Secondary Outcomes (1)

• The improvement of angina symptom at 6 months

  From the date of enrollment to the 6 month follow up.

Study Arms (1)

Patients with Post-PCI Angina

An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography (ICA).

Diagnostic Test: An advanced invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP)

Interventions

An advanced invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP) DIAGNOSTIC_TEST

AID strategy encompasses a hierarchical algorithm intended to investigate both obstructive and non-obstructive causes of myocardial ischaemia. AID strategy starts with an ICA. Angiographically severe-grade stenosis (≥90%) can be safely considered flow-limiting without further physiological assessment. Conversely, by means of a pressure guidewire, intermediate-grade stenosis will be evaluated with FFR and/or NHPR in order to determine if they are physiologically significant. Those patients with non-obstructive CAD or normal epicardial coronary arteries should undergo functional coronary tests to investigate the presence of microcirculatory and vasomotor coronary disorders, which would account for non-obstructive causes of ischaemia. Angiography derived physiology will be performed by applying functional coronary angiography to the coronary angiogram using AngioPlus Core software (Pulse Medical Technology, Shanghai, China).

Patients with Post-PCI Angina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for ICA at participating centers.

You may qualify if:

• Patients with a history of previous percutaneous coronary intervention (PCI) with drug eluting stent (DES), bare metallic stent (BMS), or drug coated balloon (DCB) due to acute coronary syndrome or chronic coronary syndrome, who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography.

You may not qualify if:

• Acute myocardial infarction (ST-segment elevation myocardial infarction \[STEMI\] and non-ST-segment elevation myocardial infarction \[NSTEMI\]).
• Age \< 18 years old.
• Pregnancy.
• Severe left ventricle systolic dysfunction (left ventricular ejection fraction ≤30 %).
• Congestive heart failure with reduced ejection fraction.
• Concomitant severe valvular heart disease.
• Severely decreased renal function (glomerular filtration rate \< 30 mL/min/1.73 m2).
• Significant epicardial coronary artery disease unable to be treated by PCI.
• Previous coronary artery bypass grafting (CABG).
• Presence of any anatomic features precluding intracoronary instrumentation with pressure guidewires.
• Contraindications to the administration of adenosine or acetylcholine.

Sponsors & Collaborators

• Fundacion Investigacion Interhospitalaria Cardiovascular: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (5)

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, Madrid, 28005, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Acalá de Henares

Madrid, Madrid, 28805, Spain

RECRUITING

Hospital Quirónsalud Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Related Publications (3)

• Jeronimo A, Paredes-Vazquez JG, Travieso A, Shabbir A, Jimenez-Quevedo P, Macaya-Ten F, Nombela-Franco L, Nunez-Gil IJ, Salinas P, Gomez-Polo JC, Garcia-Arribas D, Vilacosta I, Perez-Velasco JG, Garcia-Romo E, Garcia-Lledo A, Grande-Ingelmo JM, Fernandez-Rozas I, Alonso-Bello J, Curcio A, Fernandez-Ortiz AI, Villacastin JP, Mejia-Renteria H, Gonzalo N, Escaned J. Comprehensive diagnosis in chronic coronary syndromes combining angiography and intracoronary testing: the AID-ANGIO study. EuroIntervention. 2025 Jan 6;21(1):35-45. doi: 10.4244/EIJ-D-24-00499.

  PMID: 39773829 BACKGROUND

• Collison D, Copt S, Mizukami T, Collet C, McLaren R, Didagelos M, Aetesam-Ur-Rahman M, McCartney P, Ford TJ, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Angina After Percutaneous Coronary Intervention: Patient and Procedural Predictors. Circ Cardiovasc Interv. 2023 Apr;16(4):e012511. doi: 10.1161/CIRCINTERVENTIONS.122.012511. Epub 2023 Mar 28.

  PMID: 36974680 BACKGROUND

• Lombardi M, Boivin-Proulx LA, Jeronimo A, Mejia-Renteria H, Gonzalo N, Gori T, Mehran R, Escaned J. Angina after percutaneous coronary interventions. Eur Heart J. 2026 Jan 24;47(4):408-422. doi: 10.1093/eurheartj/ehaf771.

  PMID: 41104537 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Javier Escaned, MD, PhD

CONTACT

(0034)913303000; escaned@secadiologia.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Clinical professor

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 10, 2026
• Study Start: March 12, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

ES (5)