Invest-CTO PCI Trial

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Angina Pectoris; Chronic Total Occlusion of Coronary Artery; PROM
• Intervention / Treatment: Procedure: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen
    • Bergen, Bergen, Norway, 5021
      • Haukeland University Hospital
• United Kingdom
  • Bristol, United Kingdom, 06010
    • Bristol Health
  • London, United Kingdom, SW 0QT
    • St George´s Hospital
  • Glasgow
    • Glasgow, Glasgow, United Kingdom, G814DY
      • Golden Jubilee National Hospital
• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/ NewYork Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Invest CTO PCI; A pre-planned two staged procedure in high-risk CTO PCI	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	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]	Up to 12 weeks
Compositie safety endpoint	Death, myocardial infarction and procedural related complications	30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compositie safety endpoint	Death, myocardial infarction and procedural related complications	30 days post procedure
CTO PCI technical success	Technical success is restoration of TIMI >=2 antegrade flow with <30% residual diameter stenosis within the CTO segment	At the end of staged CTO PCI completion procedure and within 3 months
CTO PCI investment procedural success	Investment complete technical success	30 days post procedure
Composite Clinical endpoint	Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization.	30 days, 3 & 12 months
European Quality of Life-5 Dimensions	5 item measure of mobility, self-care, usual activity, pain or discomfort, and anxiety or depression . Score 0-100, where high score better.	Baseline, 3 and 12 months
Seattle angina questionnaire (SAQ7)	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.	Baseline, 3 & 12 months
Patient related outcome measures (PROM)	Qualitative interviews	Through study completion, an average of 15 months.

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Golden Jubilee National Hospital
• Investigators: Principal Investigator: Margaret B Mcentegart, PhD, Golden Jubilee National Hospital; Principal Investigator: Anja Øksnes, MD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Actual): October 9, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Chest Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Angina Pectoris; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Percutaneous Coronary Intervention
• Other Study ID Numbers: 195282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No