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Active, Not Recruiting

NCT Number: NCT04774913

Invest-CTO PCI Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Total Occlusion of Coronary Artery Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations PROM Pain Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

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

Procedure

CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks

Primary outcomes

  1. Effectiveness

    Time frame: Up to 12 weeks

    CTO PCI Procedural success, Complete technical success plus the absence of an in-hospital major adverse cardiovascular event (MACE; death, MI, or clinically driven target vessel revascularization [TVR]

  2. Compositie safety endpoint

    Time frame: 30 days post procedure

    Death, myocardial infarction and procedural related complications

Secondary outcomes

  1. CTO PCI technical success

    Time frame: At the end of staged CTO PCI completion procedure and within 3 months

    Technical success is restoration of TIMI >=2 antegrade flow with <30% residual diameter stenosis within the CTO segment

  2. CTO PCI investment procedural success

    Time frame: 30 days post procedure

    Investment complete technical success

  3. Compositie safety endpoint

    Time frame: 30 days post procedure

    Death, myocardial infarction and procedural related complications

  4. Composite Clinical endpoint

    Time frame: 30 days, 3 & 12 months

    Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization.

  5. European Quality of Life-5 Dimensions

    Time frame: Baseline, 3 and 12 months

    5 item measure of mobility, self-care, usual activity, pain or discomfort, and anxiety or depression . Score 0-100, where high score better.

  6. Seattle angina questionnaire (SAQ7)

    Time frame: Baseline, 3 & 12 months

    3 domain score of physical limitation (SAQ7-PL), angina frequency (SAQ7-AF) and quality of life (SAQ7-QL). Score 0-100, where high score better.

  7. Patient related outcome measures (PROM)

    Time frame: Through study completion, an average of 15 months.

    Qualitative interviews

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Golden Jubilee National Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 1, 2021
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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