Coronary Artery DiseaseINSIDE OCTNCT06779110
Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis
A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease and Stent Restenosis, run by San Luigi Gonzaga Hospital at 12 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease, Stent Restenosis, STENT
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 12 sitesItaly
- Study dates
- 1 Sep 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed
- Age ≥ 18 years
- Referred for angiography either in stable or ACS setting suitability for PCI through femoral or radial access
- A coronary in-stent restenosis between 70% and 99% in at least two projections in a vessel with a lumen diameter ≥ 2.25 - ≤ 5.75 mm (The severity of the stenosis should be based on visual estimation, with current online state-of-the-art angiographic equipment of the participating centres and after a mandatory dose of 50-200 mcg intracoronary of nitroglycerine.
- Stable hemodynamics
Who cannot join
- Inability to give informed consent
- Participation in another clinical study with an investigational product
- OCT pullback not technically feasible in vessel site
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Italy12 sites, 12 recruiting
- Recruiting
Osp Aosta
Aosta, Aosta
Alessandro Bernardi, MD, 0165 5431, alessandro.bernardi4@gmail.com
Alessandro Bernardi, MD
- Recruiting
Biella
Biella, Biella
Monica Verdoia, MD, 0039 015 15151, monica.verdoia@gmail.com
Monica Verdoia, MD
- Recruiting
Ospedale Universitario di Ferrara
Cona, Ferrara
Andrea Erriquez, MD, 0532 236111, andrea.erriquez90@gmail.com
Andrea Erriquez, MD
- Recruiting
Osp. S. Croce e Carle
Cuneo, Cuneo
Francesco Maiellaro, MD, 0171 641048, francescomll91@gmail.com
Francesco Maiellaro, MD
- Recruiting
Osp Universitario S. Marino
Genova, Genova
Rocco Vergallo, MD, 010 5551, rocco.vergallo@gmail.com
Rocco Vergallo, MD
- Recruiting
AOU San Luigi Gonzaga
Orbassano, Turin, 10100
Enrico Cerrato, MD PhD, 00390119026803, enrico.cerrato@gmail.com
Enrico Cerrato, MD PhD
- Recruiting
Infermi Hospital, Rivoli ASLTO3
Rivoli, Italy, 10100
Ferdinando Varbella, MD, 0119551111, varbella@gmail.com
Ferdinando Varbella, MD
- Recruiting
Ospedale di Trapani
Trapani, Trapani
Dario Buccheri, MD, 0923 809111, dariobuccheri@gmail.com
Dario Buccheri, MD
- Recruiting
AO Mauriziano
Turin, Turin, 10100
Gianmarco Annibali, MD, +39 3290222215, gianmarco.annibali@gmail.com
Gianmarco Annibali, MD
- Recruiting
AOU Città della Salute e della Scienza
Turin, Turin, 10100
Ovidio De Filippo, MD, 00390116330063, ovidio.defilippo@gmail.com
Ovidio De Filippo, MD
- Recruiting
Osp. Giovanni Bosco
Turin, TURIN, 10100
Mario Iannaccone, MD, 0039011 240 2210, mario.iannaccone@hotmail.it
Mario Iannaccone, MD
- Recruiting
Osp Vercelli
Vercelli, Vercelli
Chiara Cavallino, MD, 0161-593111, cavallino.c@gmail.com
Chiara Cavallino, MD
About this study
Official title: IN-Stent RestenosIs Detection and TrEtment by Optical Coherence Tomography
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.
Read the detailed description
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).
- Conditions
- Coronary Artery Disease, Stent Restenosis, STENT
- Being tested
- Percutaneous Coronary Intervention
- Keywords
- Percutaneous Coronary Intervention (PCI), Optimal Coherence Tomography (OCT)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Using OCT to guide PCI in ISR
| Study group | Role | What they receive |
|---|---|---|
| OCT arm (Group 1) | Active comparator | 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 Receives: Procedure: Percutaneous Coronary Intervention |
| Angio arm (Group 2) | Active comparator | 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. Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural
Secondary outcomes (5)
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
Measured: 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.
Measured: 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
Measured: Periprocedural
Number of intracoronary devices used in experimental vs control group (continuous, mean)
number of devices used including balloons stents and debulking devices
Measured: 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.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Cerrato, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779110
- Sponsor's protocol ID
- 002-2023
- Acronym
- INSIDE OCT
- Status last verified
- Dec 2024
- First submitted
- 27 Apr 2023
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN-Stent RestenosIs Detection and TrEtment by Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT06779110
- Acronym / sponsor ID
- INSIDE OCT / 002-2023
- Conditions
- Coronary Artery Disease, Stent Restenosis, STENT
- Keywords
- Percutaneous Coronary Intervention (PCI), Optimal Coherence Tomography (OCT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT arm (Group 1) | Active comparator | Procedure: Percutaneous Coronary InterventionPCI 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 |
| Angio arm (Group 2) | Active comparator | Procedure: Percutaneous Coronary InterventionPCI 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent signed
- Age ≥ 18 years
- Referred for angiography either in stable or ACS setting suitability for PCI through femoral or radial access
- A coronary in-stent restenosis between 70% and 99% in at least two projections in a vessel with a lumen diameter ≥ 2.25 - ≤ 5.75 mm (The severity of the stenosis should be based on visual estimation, with current online state-of-the-art angiographic equipment of the participating centres and after a mandatory dose of 50-200 mcg intracoronary of nitroglycerine.
- Stable hemodynamics
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Participation in another clinical study with an investigational product
- OCT pullback not technically feasible in vessel site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary InterventionUsing OCT to guide PCI in ISR | Procedure or surgery | Angio arm (Group 2), OCT arm (Group 1) |
Primary outcome
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
Time frame: Periprocedural
Delta MSA assessed by OCT (same frame) in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.
5 secondary outcomes
Clinical outcome: MACE (Major Adverse Cardiovascular Events) in experimental 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
Time frame: Periprocedural
Number of cases in which additional PCI maneuvers was performed after disclosure of OCT pullback in the entire population
Time frame: Periprocedural
Number of intracoronary devices used in experimental vs control group (continuous, mean)
Time frame: Periprocedural
Quantitative flow ratio value (QFR, mean number) at the end of PCI in experimental vs control group, continuous
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease and Stent Restenosis, run by San Luigi Gonzaga Hospital at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico Cerrato, MD, PhD (+393479317104, enricocerrato@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.