Invest-CTO PCI Trial

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04774913
• Other study ID #: 195282
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: April 2027

Study information

• Verified date: February 2023
• Source: Haukeland University Hospital
• Contact: Anja Øksnes, MD
• Phone: +4755975000
• Email: anao[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2027
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
United Kingdom	Golden Jubilee National Hospital	Glasgow
United States	Columbia University Medical Center/ NewYork Presbyterian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Golden Jubilee National Hospital

Countries where clinical trial is conducted

United States,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Compositie safety endpoint	Death, myocardial infarction and procedural related complications	30 days post procedure
Secondary	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
Secondary	CTO PCI investment procedural success	Investment complete technical success	30 days post procedure
Secondary	Composite Clinical endpoint	Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization.	30 days, 3 & 12 months
Secondary	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
Secondary	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
Secondary	Patient related outcome measures (PROM)	Qualitative interviews	Through study completion, an average of 15 months.