ACTIVE_NOT_RECRUITING

Invest-CTO PCI Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2021-12-08
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04774913

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide written informed consent
  2. * Comply with the procedural and study follow-up schedule
  3. * Planned CTO PCI in accordance with the European and American appropriateness criteria.
  4. * CTO defined as high-risk
  1. * Non-high risk CTO
  2. * Occlusion within a stent
  3. * Flush aorto-ostial occlusion of RCA and Left Main (LMS)
  4. * Limited arterial access precluding repeat procedure
  5. * Baseline non invasive testing showing non-viable target vessel territory
  6. * Contra-indication to dual antiplatelet therapy
  7. * Pregnancy
  8. * Prior radiation skin injury
  9. * Lack of informed consent

Contacts and Locations

Principal Investigator

Margaret B Mcentegart, PhD
PRINCIPAL_INVESTIGATOR
Golden Jubilee National Hospital
Anja Øksnes, MD
PRINCIPAL_INVESTIGATOR
Haukeland University Hospital

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Haukeland University Hospital

  • Margaret B Mcentegart, PhD, PRINCIPAL_INVESTIGATOR, Golden Jubilee National Hospital
  • Anja Øksnes, MD, PRINCIPAL_INVESTIGATOR, Haukeland University Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-08
Study Completion Date2026-10

Study Record Updates

Study Start Date2021-12-08
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Percutaneous coronary intervention

Additional Relevant MeSH Terms

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