CTO PCI for Chronic Total Occlusions

Recruiting at 4 trial locations

Overseen By Anja Øksnes, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Haukeland University Hospital

Disqualifiers: Non-high risk CTO, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a contraindication (reason not to use) to dual antiplatelet therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment CTO PCI for Chronic Total Occlusions?

The treatment of chronic total occlusion (CTO) with percutaneous coronary intervention (PCI) has improved over time due to better techniques and equipment, but its overall benefit is still debated. It is considered an important part of a comprehensive approach to treating coronary artery disease, alongside other treatments like bypass surgery and medication. ^{1 2 3 4 5}

Is CTO PCI generally safe for humans?

CTO PCI (Percutaneous Coronary Intervention for Chronic Total Occlusion) is considered safe and feasible when performed by experienced professionals, with high success rates and acceptable complication rates. ^{2 6 7 8 9}

How is CTO PCI treatment different from other treatments for chronic total occlusion?

CTO PCI is a specialized procedure that involves using a catheter to open blocked coronary arteries, which is more complex and challenging than standard PCI due to the complete blockage. It is often used alongside other treatments like coronary artery bypass grafting and medication to fully restore blood flow in patients with coronary artery disease. ^{1 2 3 5 10}

What is the purpose of this 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

Research Team

Margaret B Mcentegart, PhD

Principal Investigator

Golden Jubilee National Hospital

Anja Øksnes, MD

Principal Investigator

Haukeland University Hospital

Eligibility Criteria

This trial is for patients who can consent to the study, follow the schedule, and are planned for a high-risk CTO PCI according to European and American criteria. Details on who cannot participate are not provided.

Inclusion Criteria

Comply with the procedural and study follow-up schedule

Ability to provide written informed consent

CTO defined as high-risk

Exclusion Criteria

Baseline non-invasive testing showing non-viable target vessel territory

Pregnancy

My heart's main arteries are blocked at their origin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Procedure

Participants undergo the initial stage of the planned investment procedure for CTO PCI

Up to 12 weeks

1 visit (in-person)

Staged Completion Procedure

Participants undergo the staged completion of the CTO PCI procedure

Within 3 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

12 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

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

Trial Overview The trial tests whether a 'planned investment procedure' in treating chronic total occlusions (CTO) of heart arteries improves safety, success rates, and patient experience compared to traditional methods.

Participant Groups

Group I: Invest CTO PCI Experimental Treatment 1 Intervention

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

Chronic total occlusion(CTO) percutaneous coronary intervention (PCI) is already approved in European Union, United Kingdom, United States for the following indications:

Approved in European Union as CTO PCI for:

• Coronary artery disease
• Chronic total occlusion

Approved in United Kingdom as CTO PCI for:

• Coronary artery disease
• Chronic total occlusion

Approved in United States as CTO PCI for:

• Coronary artery disease
• Chronic total occlusion

Who Is Running the Clinical Trial?

Haukeland University Hospital

Lead Sponsor

Trials

493

Recruited

370,000+

Golden Jubilee National Hospital

Collaborator

Trials

48

Recruited

14,200+

Findings from Research

In a comparison of chronic total occlusion (CTO) percutaneous coronary interventions (PCI) between two eras (2012-2016 vs 2017-2019), patients in the current era showed a higher prevalence of severe angina but a lower use of ad hoc procedures, indicating a shift in patient selection and treatment strategies.

Despite changes in techniques, the technical and procedural success rates remained stable across both eras, while the incidence of in-hospital major cardiovascular events decreased from 3% to 2%, suggesting improved safety in recent CTO-PCI practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Trends in Chronic Total Occlusion Percutaneous Coronary Interventions: Insights From the PROGRESS-CTO Registry. Xenogiannis, I., Gkargkoulas, F., Karmpaliotis, D., et al.[2021]

In a study of 4030 patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusions (CTO), the overall success rate was 61.3%, which is lower than success rates for other types of lesions.

Successful CTO PCI is linked to improved survival rates, as patients with unsuccessful procedures had a significantly higher 2.5-year mortality rate, and operators performing at least 48 CTO PCIs annually had more than double the success odds compared to those with lower volumes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients With Chronic Total Occlusions Undergoing Percutaneous Coronary Interventions: Characteristics, Success, and Outcomes. Hannan, EL., Zhong, Y., Jacobs, AK., et al.[2022]

The success rate of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in 459 patients was moderately high at 64.9%, with a low incidence of serious complications (1.6%), indicating that the procedure is relatively safe.

Successful recanalisation of CTO led to less frequent surgical revascularisation and reduced angina symptoms, but it did not lower the risk of death or myocardial infarction and was associated with a higher likelihood of needing repeat PCI due to restenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous angioplasty of chronically occluded coronary arteries: long-term clinical follow-up. Drozd, J., Wójcik, J., Opalińska, E., et al.[2010]

A meta-analysis of five trials involving 1790 patients showed that chronic total occlusion (CTO) percutaneous coronary intervention (PCI) does not significantly reduce all-cause mortality, myocardial infarction, or stroke compared to no intervention, indicating similar long-term efficacy.

However, patients who underwent CTO PCI experienced a significant improvement in freedom from angina at one year, suggesting that while overall survival benefits may be limited, PCI can enhance quality of life for patients suffering from angina.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis Comparing Long-Term Clinical Outcomes of Percutaneous Coronary Intervention versus no Intervention in Patients with Chronic Total Occlusion. Ibrahem, A., Farag, M., Gue, YX., et al.[2023]

Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) is a crucial treatment that can help achieve complete revascularization in patients with coronary artery disease.

CTO PCI should be used alongside non-CTO PCI, coronary artery bypass grafting, and optimal medical therapy for the best outcomes in managing coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of coronary chronic total occlusion. Khatri, J., Abdallah, M., Ellis, S.[2018]

This trial aims to evaluate the effectiveness of percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) in patients with coronary artery disease, comparing it to optimal medical therapy (OMT) alone, with a focus on quality of life and major adverse cardiac events.

Patients will be divided into two cohorts based on their symptoms and quality of life, allowing for a targeted assessment of how CTO-PCI impacts both symptomatic relief and long-term health outcomes, which could influence future treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International randomized trial on the effect of revascularization or optimal medical therapy of chronic total coronary occlusions with myocardial ischemia - ISCHEMIA-CTO trial - rationale and design. Råmunddal, T., Holck, EN., Karim, S., et al.[2023]

Over a 9-year period, the technical success rate of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) improved significantly from 70.0% to 85.6%, despite an increase in lesion complexity, indicating that experience and advanced techniques contribute to better outcomes.

The study maintained a stable major complication rate of 4.7%, suggesting that with the right strategies, such as dual injections and retrograde approaches, CTO PCI can be performed safely even as procedural complexity increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary Strategies and Outcomes of Dedicated Chronic Total Occlusion Percutaneous Coronary Intervention Programs: A Prospective Multicentre Registry. Vanhaverbeke, M., Eertmans, W., Holvoet, W., et al.[2022]

In a study of 3271 patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusion (CTO), the overall success rate was 81.6%, indicating a favorable efficacy of the procedure in a real-world setting.

The 12-month major adverse cardiac event (MACE) rate was 9.4%, with low rates of mortality (2.4%) and myocardial infarction (0.7%), suggesting a relatively safe profile for CTO-PCI in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter experience with percutaneous coronary intervention for chronic total occlusion in Korean population: analysis of the Korean nationwide multicenter chronic total occlusion registry. Rha, SW., Choi, BG., Choi, SY., et al.[2021]

Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI) has high success rates and acceptable complication rates, particularly at experienced centers, highlighting its efficacy in improving patient symptoms.

Despite advancements in techniques and equipment, success rates for CTO PCI are significantly lower at less experienced centers, indicating the importance of specialized training and expertise in performing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latest developments in chronic total occlusion percutaneous coronary intervention. Nikolakopoulos, I., Vemmou, E., Karacsonyi, J., et al.[2022]

The review highlights significant advancements in percutaneous coronary intervention (PCI) techniques for treating chronic total occlusions (CTOs), indicating a growing field of research and clinical practice.

Key literature from 2013 demonstrates improved safety and efficacy outcomes in CTO PCI, suggesting that these interventions are becoming more effective in restoring blood flow in patients with severe coronary artery blockages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in coronary chronic total occlusion percutaneous coronary interventions: 2014 state-of-the-art update. Brilakis, ES., Karmpaliotis, D., Werner, GS., et al.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Temporal Trends in Chronic Total Occlusion Percutaneous Coronary Interventions: Insights From the PROGRESS-CTO Registry. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Patients With Chronic Total Occlusions Undergoing Percutaneous Coronary Interventions: Characteristics, Success, and Outcomes. [2022]

3. Poland pubmed.ncbi.nlm.nih.gov

Percutaneous angioplasty of chronically occluded coronary arteries: long-term clinical follow-up. [2010]

4. India pubmed.ncbi.nlm.nih.gov

Meta-analysis Comparing Long-Term Clinical Outcomes of Percutaneous Coronary Intervention versus no Intervention in Patients with Chronic Total Occlusion. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Management of coronary chronic total occlusion. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

International randomized trial on the effect of revascularization or optimal medical therapy of chronic total coronary occlusions with myocardial ischemia - ISCHEMIA-CTO trial - rationale and design. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Contemporary Strategies and Outcomes of Dedicated Chronic Total Occlusion Percutaneous Coronary Intervention Programs: A Prospective Multicentre Registry. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Multicenter experience with percutaneous coronary intervention for chronic total occlusion in Korean population: analysis of the Korean nationwide multicenter chronic total occlusion registry. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Latest developments in chronic total occlusion percutaneous coronary intervention. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Developments in coronary chronic total occlusion percutaneous coronary interventions: 2014 state-of-the-art update. [2014]