Comparing OCT guidance to angiography for treating coronary in-stent restenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Enrico Cerrato, MD, PhD
• Email: enricocerrato@gmail.com
• Phone: +393479317104

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.