Comparing OCT guidance to angiography for treating coronary in-stent restenosis
IN-Stent RestenosIs Detection and TrEtment by Optical Coherence Tomography
This study is testing whether using a special imaging technique called OCT can help treat patients with blocked heart stents better than the usual method of using angiography.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | San Luigi Gonzaga Hospital Academic / other |
| Locations | 12 sites (Aosta, Aosta and 11 other locations) |
| Trial ID | NCT06779110 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of using optical coherence tomography (OCT) guidance versus traditional angiography guidance for percutaneous coronary intervention (PCI) in patients with coronary in-stent restenosis. Patients with significant restenosis will be randomly assigned to receive either OCT-guided PCI or angiography-guided PCI. The study aims to determine if OCT can improve outcomes in treating this condition, which remains a challenge despite advancements in stent technology. The trial will involve multiple centers and will assess the acute performance of the interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant coronary in-stent restenosis suitable for PCI.
Not a fit: Patients unable to provide informed consent or those with technical limitations for OCT may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with coronary in-stent restenosis.
How similar studies have performed: While OCT has shown promise in other cardiac interventions, its specific application in treating in-stent restenosis is still being explored, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Inability to give informed consent * Participation in another clinical study with an investigational product * OCT pullback not technically feasible in vessel site
Where this trial is running
Aosta, Aosta and 11 other locations
- Osp Aosta — Aosta, Aosta, Italy (Recruiting)
- Biella — Biella, Biella, Italy (Recruiting)
- Osp. S. Croce e Carle — Cuneo, Cuneo, Italy (Recruiting)
- Ospedale Universitario di Ferrara — Cona, Ferrara, Italy (Recruiting)
- Osp Universitario S. Marino — Genova, Genova, Italy (Recruiting)
- Infermi Hospital, Rivoli ASLTO3 — Rivoli, Italy, Italy (Recruiting)
- Ospedale di Trapani — Trapani, Trapani, Italy (Recruiting)
- AOU San Luigi Gonzaga — Orbassano, Turin, Italy (Recruiting)
- AO Mauriziano — Turin, Turin, Italy (Recruiting)
- AOU Città della Salute e della Scienza — Turin, Turin, Italy (Recruiting)
- Osp. Giovanni Bosco — Turin, Turin, Italy (Recruiting)
- Osp Vercelli — Vercelli, Vercelli, Italy (Recruiting)
Study contacts
- Study coordinator: Enrico Cerrato, MD, PhD
- Email: enricocerrato@gmail.com
- Phone: +393479317104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.