ClinicalTrials.gg
RecruitingNCT07638137Updated Jun 10, 2026

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

An observational study in Angina (Stable), Percutaneous Coronary Intervention (PCI) and INOCA (Ischemia With Non Obstructive Coronary Artery Disease), sponsored by Fundacion Investigacion Interhospitalaria Cardiovascular. Recruiting at 5 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Fundacion Investigacion Interhospitalaria Cardiovascular · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
246
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

AID Post-PCI Angina is as an observational, prospective, single-cohort, multicenter study intended to investigate for 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. Secondary objective is to investigate the benefits of applying the AID strategy in the improvement of angina symptoms at 6 months, evaluated by the Seattle Angina Questionnaire (SAQ). This study is a multicenter study and will be conducted in 5 hospitals across Spain.

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, will be enrolled in the study.

After acquiring patient's informed consent, ICA will be performed with the application of the structure AID strategy to evaluate both obstructive and non-obstructive cause of myocardial ischemia. AID strategy begins with invasive coronary angiography. Angiographically severe-grade stenosis (≥90%) can be safely considered as cause of a myocardial ischemia without further physiological assessment. Conversely, by means of a pressure guidewire, intermediate-grade stenosis would be evaluated with fractional flow reserve (FFR) and/or non-hyperaemic pressure ratios (NHPR) in order to determine if they are physiologically relevant. Those patients with non-obstructive CAD or normal epicardial coronary arteries would undergo functional coronary tests to investigate the presence of microcirculatory and vasomotor coronary disorders, which would account for non-obstructive causes of ischaemia. Patient's angiograms in both index procedure and previous PCI will be assessed by functional coronary angiography using the AngioPlus Core software (Pulse Medical Technology, Shanghai, China) for angiography derived physiology (ADP). By combining the results from the AID strategy and ADP, origin of obstructive disease can be defined as progression of CAD, post-PCI residual disease, suboptimal stenting and in stent restenosis (ISR.

Treatment will be decided by the operators according to the result. Patient will be follow-up at 1, 6, and 12 months after the procedure. At each follow-up, patients will complete the Seattle Angina Questionnaire (SAQ) to evaluate for angina symptom.

02

Conditions studied

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

Keywords

  • Angina
  • Percutaneous Coronary Intervention
  • Chronic Coronary Syndrome
03

In context

Angina, Stable

343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.

This study's planned enrollment of 246 is below the median of 508 across 103 observational studies indexed under Angina, Stable.

Browse Angina, Stable studies →

Lead sponsor

Fundacion Investigacion Interhospitalaria Cardiovascular is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 ( ≤30 %).
  • Congestive heart failure with reduced ejection fraction.
  • Concomitant severe valvular heart disease.
  • Severely decreased renal function ( \< 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.
  • to the administration of adenosine or acetylcholine.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
246 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testAn advanced invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP)

    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).

06

What researchers measure

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

    Time frame: Baseline.

Secondary outcomes

  1. The improvement of angina symptom at 6 months

    To investigate the benefits of applying the advance invasive diagnosis (AID) strategy in the improvement of angina symptoms at 6 months, evaluated by the Seattle Angina Questionnaire (SAQ). The SAQ score will be reported on a scale of 0-100 with the higher score means less angina symptom (better outcome).

    Time frame: From the date of enrollment to the 6 month follow up.

07

Study locations

5 of 5 sites recruiting
08

References and documents

Publications

  • 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. PubMed 39773829 ↗
  • 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. PubMed 36974680 ↗
  • 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. PubMed 41104537 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07638137
Lead sponsor
Fundacion Investigacion Interhospitalaria Cardiovascular
Collaborators
Instituto de Salud Carlos III
Responsible party
Javier Escaned (Principle investigator, Clinical professor, Hospital San Carlos, Madrid) — Principal investigator
First posted
Jun 10, 2026
Start date
Mar 12, 2025
Primary completion
Mar 30, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Jun 10, 2026

Study contacts

Javier Escaned, MD, PhD
Contact
escaned@secadiologia.es
(0034)913303000 ext. 3438

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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