Invest-CTO PCI Trial

Description

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

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Study Overview

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Study Details

Study overview

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

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

Invest-CTO PCI Trial

Condition
Chronic Total Occlusion of Coronary Artery
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Medical Center/ NewYork Presbyterian Hospital, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Ability to provide written informed consent
  • * Comply with the procedural and study follow-up schedule
  • * Planned CTO PCI in accordance with the European and American appropriateness criteria.
  • * CTO defined as high-risk
  • * Non-high risk CTO
  • * Occlusion within a stent
  • * Flush aorto-ostial occlusion of RCA and Left Main (LMS)
  • * Limited arterial access precluding repeat procedure
  • * Baseline non invasive testing showing non-viable target vessel territory
  • * Contra-indication to dual antiplatelet therapy
  • * Pregnancy
  • * Prior radiation skin injury
  • * Lack of informed consent

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Haukeland University Hospital,

Margaret B Mcentegart, PhD, PRINCIPAL_INVESTIGATOR, Golden Jubilee National Hospital

Anja Øksnes, MD, PRINCIPAL_INVESTIGATOR, Haukeland University Hospital

Study Record Dates

2027-04