Chronic Total Occlusion of Coronary ArteryNCT04774913
Invest-CTO PCI Trial
A study testing Chronic total occlusion(CTO) percutaneous coronary intervention (PCI) in people with Chronic Total Occlusion of Coronary Artery and Angina Pectoris, run by Haukeland University Hospital at 5 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery, Angina Pectoris, Quality of Life
- What is being tested?
- Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 8 Dec 2021to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Prior radiation skin injury
- Lack of informed consent
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom3 sites
Bristol Health
Bristol, 06010
Golden Jubilee National Hospital
Glasgow, Glasgow, G814DY
St George´s Hospital
London, SW 0QT
United States1 site
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, 10032
About this study
Official title: 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.
Read more
The investigators hypothesize that
- A planned investment procedure in the treatment of CTOs will be associated with improved patient safety
- A planned investment procedure will be associated with improved cumulative procedure success rates
- A planned two stage procedure will be associated with improved patient experience
- Being tested
- Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)
- Keywords
- Percutaneous coronary intervention
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)Procedure or surgery
CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Invest CTO PCI | Experimental | A pre-planned two staged procedure in high-risk CTO PCI Receives: Procedure: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: Up to 12 weeks
Compositie safety endpoint
Death, myocardial infarction and procedural related complications
Measured: 30 days post procedure
Secondary outcomes (7)
CTO PCI technical success
Technical success is restoration of TIMI >=2 antegrade flow with <30% residual diameter stenosis within the CTO segment
Measured: At the end of staged CTO PCI completion procedure and within 3 months
CTO PCI investment procedural success
Investment complete technical success
Measured: 30 days post procedure
Compositie safety endpoint
Death, myocardial infarction and procedural related complications
Measured: 30 days post procedure
Composite Clinical endpoint
Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 & 12 months
Patient related outcome measures (PROM)
Qualitative interviews
Measured: Through study completion, an average of 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start8 Dec 2021
- Primary completion9 Oct 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm, international, multicenter study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Responsible party
- Sponsor
- Investigators
- Margaret B Mcentegart, PhD, Principal investigator, Golden Jubilee National HospitalAnja Øksnes, MD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774913
- Sponsor's protocol ID
- 195282
- Status last verified
- Oct 2025
- First submitted
- 17 Feb 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI
- ClinicalTrials.gov ID
- NCT04774913
- Acronym / sponsor ID
- 195282
- Keywords
- Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- A planned investment procedure in the treatment of CTOs will be associated with improved patient safety
- A planned investment procedure will be associated with improved cumulative procedure success rates
- A planned two stage procedure will be associated with improved patient experience
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm, international, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Invest CTO PCI | Experimental | Procedure: Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)A pre-planned two staged procedure in high-risk CTO PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Invest CTO PCI |
Primary outcome
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]
Compositie safety endpoint
Time frame: 30 days post procedure
Death, myocardial infarction and procedural related complications
7 secondary outcomes
CTO PCI technical success
Time frame: At the end of staged CTO PCI completion procedure and within 3 months
CTO PCI investment procedural success
Time frame: 30 days post procedure
Compositie safety endpoint
Time frame: 30 days post procedure
Composite Clinical endpoint
Time frame: 30 days, 3 & 12 months
European Quality of Life-5 Dimensions
Time frame: Baseline, 3 and 12 months
Seattle angina questionnaire (SAQ7)
Time frame: Baseline, 3 & 12 months
Patient related outcome measures (PROM)
Time frame: Through study completion, an average of 15 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret B Mcentegart, PhD principal investigator
Golden Jubilee National Hospital
Anja Øksnes, MD principal investigator
Haukeland University Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic total occlusion(CTO) percutaneous coronary intervention (PCI) in people with Chronic Total Occlusion of Coronary Artery and Angina Pectoris, run by Haukeland University Hospital at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, United States, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.