An interventional study of Percutaneous Coronary Intervention in Coronary Artery Disease, Stent Restenosis and STENT, sponsored by San Luigi Gonzaga Hospital. Recruiting at 12 sites in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by San Luigi Gonzaga Hospital · Not applicable, Interventional, and Treatment
Although advances in drug-eluting stents (DES) have substantially reduced the risk of coronary in-stent restenosis (ISR) and the need for target lesion revascularisation (TLR), ISR persists. There are several treatment options for ISR (conventional balloon angioplasty, cutting or scoring balloons, drug-coated balloons, repeat DES implantation or bypass surgery). Coronary imaging is mandatory to perform PCI on ISR. Optimal coherence tomography (OCT) is an excellent option to guide PCI, but its role in ISR-PCI remains unclear. The INSIDE OCT Trial aims to compare the acute performance of PCI for ISR, either guided by OCT and angiography or by angiography alone.
INSIDE-OCT is an investigator-initiated, randomised, multicenter, non-blinded trial.
Patients presenting with acute coronary syndrome or stable ischemic heart disease and ISR (angiographic stenosis between 70% and 99% in at least two projections, in a vessel with a lumen diameter ≥ 2.25 - ≤ 5.75 mm) with PCI indication will be randomised (1:1) to undergo either PCI guided by OCT (Group 1) or PCI with angiographic guidance only (Group 2).
Nowadays, PCI is performed following current guidelines and clinical practice. Any manoeuvre is left to the operator's discretion. Any approved intracoronary gears could be used (multiple wires, compliant, non-compliant, cutting, scoring balloons, Drug coated balloons, new stents implantation etc.).
Randomisation will be performed on the online eCRF site immediately after the end of the diagnostic angiography after acquiring the patient's study informed consent and after reviewing inclusion/exclusion criteria.
Randomisation will generate two groups:
PCI of ISR guided by OCT (group 1): in this case, the operator has to perform at least one OCT run before and one OCT run at the end of PCI. The operator is left free to review the OCT run in the console directly and is left free to perform during PCI any additional OCT run.
PCI of ISR guided by angiography (group 2): in this case, the operator has to perform PCI following angiography. To allow outcome computation, OCT will also be performed in this group at the beginning and the end of PCI. However, the operator will be wholly blinded to any OCT findings. A detailed description of the blinding modality is reported in the following paragraph.
Blinding: In Group 2, OCT will be performed at the beginning of the procedure, although the operator will be blinded to any OCT findings. In practice, the operator will perform OCT pullback properly, advancing the probe in the target vessel following angio guidance but without viewing the OCT monitor in the cath lab. A trained nurse/technician not involved in any decision regarding the procedure will guide the operator to perform an OCT pullback correctly and will check immediately if the OCT run is consistent with the current standard of quality. The operator could not receive any information from the OCT run recorded at this stage and had to proceed with the PCI procedure with angio-only guidance Therefore, the operator will declare the end of the procedure after completing all PCI manoeuvres judged necessary to obtain an excellent angiographic result. At this stage, an OCT pullback will be performed again to appraise OCT final data required for primary endpoint computation.
Therefore, the operator should evaluate the OCT runs, and he will be left free to perform additional PCI manoeuvres to optimise the result if necessary.
In groups 1 and 2, the operator should detail his PCI planned strategy before and after OCT runs. Changes in PCI planning after OCT disclosure will be recorded in both groups (see secondary outcomes).
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 360 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →San Luigi Gonzaga Hospital is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PCI of ISR guided by OCT (group 1): in this case, the operator has to perform at least one OCT run before and one OCT run at the end of PCI. The operator is left free to review the OCT run in the console directly and is left free to perform during PCI any additional OCT run. Dedicated flow-chart of treatment should be followed by operator during PCI
Procedure: Percutaneous Coronary Intervention
PCI of ISR guided by angiography (group 2): in this case, the operator has to perform PCI following angiography. To allow outcome computation, OCT will also be performed in this group at the beginning and the end of PCI, although the operator will be wholly blinded to any OCT findings. A detailed description of the blinding modality is reported in the following paragraph.
Procedure: Percutaneous Coronary Intervention
Using OCT to guide PCI in ISR
Imaging Outcome (powered): Delta MSA defined as: cross Sectional Area (CSA,mm2) post-PCI minus CSA (mm2) at baseline in the same coronary restenotic segment, continuous measure
Delta MSA assessed by OCT (same frame) in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.
Time frame: Periprocedural
Clinical outcome: MACE (Major Adverse Cardiovascular Events) in experimental vs control group
Time-to-first-event rate of the composite outcome of all cause of death, non-fatal MI, ID-TLR at 1 year in experimental group vs control group
Time frame: 1-year
Imaging Outcome: Delta MSA defined as: cross Sectional Area (CSA,mm2) post-PCI minus CSA (mm2) at baseline in the same coronary restenotic segment, continuous measure
Delta MSA assessed by OCT (same frame) in control (angio-guided) arm, in patients treated with additional manouvers after OCT disclosure, measured at an independent OCT core laboratory blinded to imaging modality assignment.
Time frame: Periprocedural
Number of cases in which additional PCI maneuvers was performed after disclosure of OCT pullback in the entire population
Additional PCI manouvers performed by operators after OCT disclosure including changings in size of balloons, any balloon dilatations, cutting/scoring, IVL, DEB, DES implantation
Time frame: Periprocedural
Number of intracoronary devices used in experimental vs control group (continuous, mean)
number of devices used including balloons stents and debulking devices
Time frame: Periprocedural
Quantitative flow ratio value (QFR, mean number) at the end of PCI in experimental vs control group, continuous
Mean Quantitative flow Ratio value assessed by QFR sofware in each randomized arm, measured at an independent core laboratory blinded to imaging modality assignment.
Time frame: Periprocedural
Number of patient with device-related (OCT) complications in the whole population
number of cases with perforations, dissections, abrupt vessel closure, TIMI flow reduction or other coronary complications related to advancement or retrieval or OCT probe pullback
Time frame: periprocedural
Number of patient with acute kidney injury in the entire study population.
Acute kidney injury (AKI) was defined as the presence of any of the following (not graded): elevation in the serum creatinine level by \>= 0.3 mg/dl within 48hours; or increase \>= 1.5 times tnat at baseline or urine volume \< 0.5 ml/kg/h for 6 hours
Time frame: within hospitalization
Clinical outcome: MACE (Major Adverse Cardiovascular Events)
Time-to-first-event rate of the composite outcome of all cause of death, non-fatal MI, ID-TLR at 1 year in experimental group vs historical cohort of patients with ISR treated with angio-only guided PCI in the current DES generation
Time frame: within 1 year
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
San Luigi Gonzaga Hospital