Invest-CTO PCI Trial

NCT04774913 | Active Not Recruiting DMC

• 1 other identifier: 195282
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 5

Brief 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. 1.A planned investment procedure in the treatment of CTOs will be associated with improved patient safety
2. 2.A planned investment procedure will be associated with improved cumulative procedure success rates
3. 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

Keywords

Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• CTO PCI technical success

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

• CTO PCI investment procedural success

  30 days post procedure

• Compositie safety endpoint

  30 days post procedure

• Composite Clinical endpoint

  30 days, 3 & 12 months

• European Quality of Life-5 Dimensions

  Baseline, 3 and 12 months

Study Arms (1)

Invest CTO PCI

EXPERIMENTAL

A pre-planned two staged procedure in high-risk CTO PCI

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

Interventions

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

Invest CTO PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Golden Jubilee National Hospital: collaborator

Study Sites (5)

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

Haukeland University Hospital

Bergen, Bergen, 5021, Norway

Location

Golden Jubilee National Hospital

Glasgow, Glasgow, G814DY, United Kingdom

Location

Bristol Health

Bristol, 06010, United Kingdom

Location

St George´s Hospital

London, SW 0QT, United Kingdom

Location

MeSH Terms

Conditions

Angina Pectoris

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Margaret B Mcentegart, PhD

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

• Anja Øksnes, MD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single arm, international, multicenter study

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 1, 2021
• Study Start: December 8, 2021
• Primary Completion: October 9, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (3); NO (1)