Actively Recruiting
Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis
Led by San Luigi Gonzaga Hospital · Updated on 2025-01-16
360
Participants Needed
12
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Intracoronary Optical Coherence Tomography Guidance Vs. Angiography Only Guidance for Treatment of Coronary In-stent Restenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older
- Scheduled for angiography due to stable or acute coronary syndrome and suitable for PCI by femoral or radial access
- Coronary in-stent restenosis with 70% to 99% narrowing in at least two angiographic projections in a vessel sized 2.25 to 5.75 mm, confirmed after nitroglycerine administration
- Stable hemodynamic condition
You will not qualify if you...
- Unable to give informed consent
- Currently participating in another clinical study involving an investigational product
- OCT imaging not technically feasible at the target vessel site
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Osp Aosta
Aosta, Aosta, Italy
Actively Recruiting
2
Biella
Biella, Biella, Italy
Actively Recruiting
3
Osp. S. Croce e Carle
Cuneo, Cuneo, Italy
Actively Recruiting
4
Ospedale Universitario di Ferrara
Cona, Ferrara, Italy
Actively Recruiting
5
Osp Universitario S. Marino
Genova, Genova, Italy
Actively Recruiting
6
Infermi Hospital, Rivoli ASLTO3
Rivoli, Italy, Italy, 10100
Actively Recruiting
7
Ospedale di Trapani
Trapani, Trapani, Italy
Actively Recruiting
8
AOU San Luigi Gonzaga
Orbassano, Turin, Italy, 10100
Actively Recruiting
9
AO Mauriziano
Turin, Turin, Italy, 10100
Actively Recruiting
10
AOU Città della Salute e della Scienza
Turin, Turin, Italy, 10100
Actively Recruiting
11
Osp. Giovanni Bosco
Turin, TURIN, Italy, 10100
Actively Recruiting
12
Osp Vercelli
Vercelli, Vercelli, Italy
Actively Recruiting
Research Team
E
Enrico Cerrato, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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