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RECRUITING
NCT06779110
NA

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

Sponsor: San Luigi Gonzaga Hospital

View on ClinicalTrials.gov

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.

Official title: IN-Stent RestenosIs Detection and TrEtment by Optical Coherence Tomography

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2024-09-01

Completion Date

2028-09-01

Last Updated

2025-01-16

Healthy Volunteers

No

Interventions

PROCEDURE

Percutaneous Coronary Intervention

Using OCT to guide PCI in ISR

Locations (12)

Osp Aosta

Aosta, Aosta, Italy

Biella

Biella, Biella, Italy

Osp. S. Croce e Carle

Cuneo, Cuneo, Italy

Ospedale Universitario di Ferrara

Cona, Ferrara, Italy

Osp Universitario S. Marino

Genova, Genova, Italy

Infermi Hospital, Rivoli ASLTO3

Rivoli, Italy, Italy

Ospedale di Trapani

Trapani, Trapani, Italy

AOU San Luigi Gonzaga

Orbassano, Turin, Italy

AO Mauriziano

Turin, Turin, Italy

AOU Città della Salute e della Scienza

Turin, Turin, Italy

Osp. Giovanni Bosco

Turin, TURIN, Italy

Osp Vercelli

Vercelli, Vercelli, Italy