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

NCT06779110 | Recruiting DMC

• 1 other identifier: 002-2023
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Coronary Artery Disease; Stent Restenosis; STENT

Keywords

Percutaneous Coronary Intervention (PCI); Optimal Coherence Tomography (OCT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clinical outcome: MACE (Major Adverse Cardiovascular Events) in experimental 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

  Periprocedural

• Number of cases in which additional PCI maneuvers was performed after disclosure of OCT pullback in the entire population

  Periprocedural

• Number of intracoronary devices used in experimental vs control group (continuous, mean)

  Periprocedural

• Quantitative flow ratio value (QFR, mean number) at the end of PCI in experimental vs control group, continuous

  Periprocedural

Other Outcomes (3)

• Number of patient with device-related (OCT) complications in the whole population

  periprocedural

• Number of patient with acute kidney injury in the entire study population.

  within hospitalization

• Clinical outcome: MACE (Major Adverse Cardiovascular Events)

  within 1 year

Study Arms (2)

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

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.

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention PROCEDURE

Using OCT to guide PCI in ISR

Angio arm (Group 2); OCT arm (Group 1)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (12)

Osp Aosta

Aosta, Aosta, Italy

RECRUITING

Biella

Biella, Biella, Italy

RECRUITING

Osp. S. Croce e Carle

Cuneo, Cuneo, Italy

RECRUITING

Ospedale Universitario di Ferrara

Cona, Ferrara, Italy

RECRUITING

Osp Universitario S. Marino

Genova, Genova, Italy

RECRUITING

Infermi Hospital, Rivoli ASLTO3

Rivoli, Italy, 10100, Italy

RECRUITING

Ospedale di Trapani

Trapani, Trapani, Italy

RECRUITING

AOU San Luigi Gonzaga

Orbassano, Turin, 10100, Italy

RECRUITING

AO Mauriziano

Turin, Turin, 10100, Italy

RECRUITING

AOU Città della Salute e della Scienza

Turin, Turin, 10100, Italy

RECRUITING

Osp. Giovanni Bosco

Turin, TURIN, 10100, Italy

RECRUITING

Osp Vercelli

Vercelli, Vercelli, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Enrico Cerrato, MD, PhD

CONTACT

+393479317104; enricocerrato@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: January 16, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (12)