IN-Stent RestenosIs Detection and TrEtment by Optical Coherence Tomography

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Osp Aosta
RECRUITING
Aosta
Biella
RECRUITING
Biella
Ospedale Universitario di Ferrara
RECRUITING
Cona
Osp. S. Croce e Carle
RECRUITING
Cuneo
Osp Universitario S. Marino
RECRUITING
Genova
AOU San Luigi Gonzaga
RECRUITING
Orbassano
Infermi Hospital, Rivoli ASLTO3
RECRUITING
Rivoli
Ospedale di Trapani
RECRUITING
Trapani
AO Mauriziano
RECRUITING
Turin
AOU Città della Salute e della Scienza
RECRUITING
Turin
Osp. Giovanni Bosco
RECRUITING
Turin
Osp Vercelli
RECRUITING
Vercelli
Contact Information
Primary
Enrico Cerrato, MD, PhD
enricocerrato@gmail.com
+393479317104
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 360
Treatments
Active_comparator: OCT arm (Group 1)
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
Active_comparator: Angio arm (Group 2)
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.
Sponsors
Leads: San Luigi Gonzaga Hospital

This content was sourced from clinicaltrials.gov