CTO PCI for Chronic Total Occlusions

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Margaret B Mcentegart, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Haukeland University Hospital

Disqualifiers: Non-high risk CTO, Pregnancy, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

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

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.

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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.

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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.

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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.

Trial 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)

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia University Medical Center/ NewYork Presbyterian Hospital New York, NY

Who Is Running the Clinical Trial?

Haukeland University Hospital Lead Sponsor

Golden Jubilee National Hospital Collaborator

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] Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has significantly evolved in recent years.

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

Patients With Chronic Total Occlusions Undergoing Percutaneous Coronary Interventions: Characteristics, Success, and Outcomes. [2022] Percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) has been identified as a beneficial treatment, but there is limited information about its use in everyday practice.

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

Percutaneous angioplasty of chronically occluded coronary arteries: long-term clinical follow-up. [2010] Percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) is one of the most demanding procedures in interventional cardiology. In spite of growing experience and technological progress, efficacy of PCI of CTO remains lower than that of standard PCI.

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] Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has substantially improved due to increasing operator experience and advancements in equipment, techniques, and management algorithms. However, the overall benefit of CTO PCI remains controversial, particularly since only a few randomized trials have been reported to date.

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

Management of coronary chronic total occlusion. [2018] Percutaneous coronary intervention (PCI) for coronary artery chronic total occlusion (CTO) is an important treatment to be used in conjunction with non-CTO PCI, coronary artery bypass grafting, and optimal medical therapy to achieve complete revascularization in patients with coronary artery disease.

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] Chronic total occlusions (CTO) are frequent among patients with coronary artery disease. Revascularization with percutaneous coronary intervention (PCI) is safe and feasible in experienced hands. However, randomized data are needed to demonstrate symptomatic as well as prognostic effect of CTO-PCI compared to optimal medical therapy alone.

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] The field of CTO PCI is expanding, but successful and safe percutaneous coronary intervention (PCI) of coronary chronic total occlusions (CTO) requires a substantial resource and experience investment. We aimed to assess temporal trends in strategies and outcomes of 2 dedicated programs for CTO PCI.

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] Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) remains challenging because of limited success and higher target vessel failure rates. Detailed safety and efficacy data for CTO-PCI from a multicenter real-world Korean registry are limited.

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

Latest developments in chronic total occlusion percutaneous coronary intervention. [2022] Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI) is now performed with high success rates and acceptable complication rates.

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

Developments in coronary chronic total occlusion percutaneous coronary interventions: 2014 state-of-the-art update. [2014] Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is a rapidly developing field. In the present review, we summarize the most important CTO PCI related literature published in 2013.