Invest-CTO PCI Trial

Last updated: February 26, 2024
Sponsor: Haukeland University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Pain

Coronary Artery Disease

Circulation Disorders

Treatment

Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)

Clinical Study ID

NCT04774913
195282
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion 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

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)
Phase:
Study Start date:
December 08, 2021
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Haukeland University Hospital

    Bergen, 5021
    Norway

    Active - Recruiting

  • Golden Jubilee National Hospital

    Glasgow, G814DY
    United Kingdom

    Active - Recruiting

  • Columbia University Medical Center/ NewYork Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

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