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Invest-CTO PCI Trial

NCT04774913 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-11-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Golden Jubilee National Hospital

    collaborator OTHER_GOV

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Margaret B Mcentegart, PhD · Golden Jubilee National Hospital

  • Anja Øksnes, MD · Haukeland University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-08
Primary Completion
2025-10-09
Completion
2026-10-31

Countries

  • United States
  • Norway
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04774913 on ClinicalTrials.gov