NCT04774913

Invest-CTO PCI Trial

Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Following unsuccessful CTO crossing a CTO modification procedure is sometimes performed. CTO PCI registries where plaque modification has been performed in some patients, report this to be safe, and associated with higher success rates at subsequent attempts. It has never been investigated whether a planned investment procedure, with an intention that both the initial and staged completion PCI are of shorter duration, could improve safety and efficacy. The investigators hypothesize that 1. A planned investment procedure in the treatment of CTOs will be associated with improved patient safety 2. A planned investment procedure will be associated with improved cumulative procedure success rates 3. A planned two stage procedure will be associated with improved patient experience

Conditions

• Chronic Total Occlusion of Coronary Artery
• Angina Pectoris
• Quality of Life
• PROM

Interventions

Type	Name	Description
PROCEDURE	Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)	CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks

Timeline

• Start date: 2021-12-08
• Primary completion: 2025-10-09
• Completion: 2026-10-01
• First posted: 2021-03-01
• Last updated: 2025-11-21

Locations

5 sites across 3 countries: United States, Norway, United Kingdom