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Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis
Sponsor: San Luigi Gonzaga Hospital
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
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