Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis (INSIDE OCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Stent Restenosis; STENT
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention

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 Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enrico Cerrato, MD, PhD; Phone Number: +393479317104; Email: enricocerrato@gmail.com

Study Locations

• Italy
  • Aosta, Italy
    • Recruiting
    • Osp Aosta
    • Contact: Alessandro Bernardi, MD; Phone Number: 0165 5431; Email: alessandro.bernardi4@gmail.com
    • Contact: Alessandro Bernardi, MD
    • Contact: Tarek Shail, MD
  • Biella, Italy
    • Recruiting
    • Biella
    • Contact: Monica Verdoia, MD; Phone Number: 0039 015 15151; Email: monica.verdoia@gmail.com
    • Contact: Monica Verdoia, MD
  • Cuneo, Italy
    • Recruiting
    • Osp. S. Croce e Carle
    • Contact: Francesco Maiellaro, MD; Phone Number: 0171 641048; Email: francescomll91@gmail.com
    • Contact: Francesco Maiellaro, MD
  • Genova, Italy
    • Recruiting
    • Osp Universitario S. Marino
    • Contact: Rocco Vergallo, MD; Phone Number: 010 5551; Email: rocco.vergallo@gmail.com
    • Contact: Rocco Vergallo, MD
  • Rivoli, Italy, 10100
    • Recruiting
    • Infermi Hospital, Rivoli ASLTO3
    • Contact: Ferdinando Varbella, MD; Phone Number: 0119551111; Email: varbella@gmail.com
    • Contact: Ferdinando Varbella, MD
    • Contact: Simone Zecchino, MD
  • Trapani, Italy
    • Recruiting
    • Ospedale di Trapani
    • Contact: Dario Buccheri, MD; Phone Number: 0923 809111; Email: dariobuccheri@gmail.com
    • Contact: Dario Buccheri, MD
  • Turin, Italy, 10100
    • Recruiting
    • AO Mauriziano
    • Contact: Gianmarco Annibali, MD; Phone Number: +39 3290222215; Email: gianmarco.annibali@gmail.com
    • Contact: Gianmarco Annibali, MD
    • Contact: Giorgio Quadri, MD
  • Turin, Italy, 10100
    • Recruiting
    • AOU Città della Salute e della Scienza
    • Contact: Ovidio De Filippo, MD; Phone Number: 00390116330063; Email: ovidio.defilippo@gmail.com
    • Contact: Ovidio De Filippo, MD
    • Contact: Fabrizio D'Ascenzo, MD
  • Turin, Italy, 10100
    • Recruiting
    • Osp. Giovanni Bosco
    • Contact: Mario Iannaccone, MD; Phone Number: 0039011 240 2210; Email: mario.iannaccone@hotmail.it
    • Contact: Mario Iannaccone, MD
    • Contact: Francesco Colombo, MD
  • Vercelli, Italy
    • Recruiting
    • Osp Vercelli
    • Contact: Chiara Cavallino, MD; Phone Number: 0161-593111; Email: cavallino.c@gmail.com
    • Contact: Chiara Cavallino, MD
    • Contact: Mohamed Abdirashid, MD
    • Contact: Marco Franzino, MD
  • Ferrara
    • Cona, Ferrara, Italy
      • Recruiting
      • Ospedale Universitario di Ferrara
      • Contact: Simone Biscaglia, MD
      • Contact: Andrea Erriquez, MD; Phone Number: 0532 236111; Email: andrea.erriquez90@gmail.com
      • Contact: Andrea Erriquez, MD
  • Turin
    • Orbassano, Turin, Italy, 10100
      • Recruiting
      • AOU San Luigi Gonzaga
      • Contact: Enrico Cerrato, MD PhD; Phone Number: 00390119026803; Email: enrico.cerrato@gmail.com
      • Contact: Enrico Cerrato, MD PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Inability to give informed consent
• Participation in another clinical study with an investigational product
• OCT pullback not technically feasible in vessel site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OCT arm (Group 1); 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; Using OCT to guide PCI in ISR
Active Comparator: Angio arm (Group 2); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	Periprocedural
Number of intracoronary devices used in experimental vs control group (continuous, mean)	number of devices used including balloons stents and debulking devices	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.	Periprocedural

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	within 1 year

Collaborators and Investigators

• Sponsor: San Luigi Gonzaga Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention (PCI); Optimal Coherence Tomography (OCT)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 002-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No