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

RecruitingNAAges 18 Years - 99 YearsAllSan Luigi Gonzaga Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Informed consent signed * Age โ‰ฅ 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 โ‰ฅ 2.25 - โ‰ค 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
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What it tests

  • Percutaneous Coronary Intervention
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Where

12 sites
Osp Aosta
Aosta, Italy
Biella
Biella, Italy
Osp. S. Croce e Carle
Cuneo, Italy
Ospedale Universitario di Ferrara
Cona, Italy
Osp Universitario S. Marino
Genova, Italy
Infermi Hospital, Rivoli ASLTO3
Rivoli, Italy
Ospedale di Trapani
Trapani, Italy
AOU San Luigi Gonzaga
Orbassano, Italy

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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