Active not recruitingNAINTERVENTIONAL

Invest-CTO PCI Trial

This research is investigating a new way to treat very stubborn blockages in the heart's blood vessels, known as Chronic Total Occlusions (CTOs). Sometimes for these blockages, initial attempts to clear them aren't successful. This study proposes a 'planned investment procedure,' which means dividing the treatment into two separate, shorter sessions instead of trying to clear the blockage all at once in a single, longer procedure. Doctors believe this two-stage approach might be safer for patients, lead to a higher chance of successfully clearing the blockage over time, and result in a better overall experience for the patient. The study aims to gather evidence to see if this planned two-step method truly offers these benefits.

At a glance

Status

Active not recruiting

Phase

Sponsor

Haukeland University Hospital

Enrolment target

200

Start

08 Dec 2021

Estimated completion

01 Oct 2026

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

What is this study about?

Imagine the pipes that carry blood to your heart get completely blocked for a long time. These blockages are called Chronic Total Occlusions (CTOs), and they can cause chest pain (angina) and affect your quality of life. Doctors often try to clear these blockages using a procedure called PCI, where a tiny balloon and sometimes a stent are used to open up the artery.

Sometimes, clearing these tough blockages can be very difficult and might take a long time in one go. In some cases, doctors have tried to 'modify' the blockage first, making it easier to clear later. This study is looking at a new idea: what if we purposely plan to do the clearance in two shorter steps? The first step would be an 'investment' procedure, aimed at making the blockage easier to treat, followed by a second session to fully clear it.

The main aim of this study is to see if this planned two-step approach is better than trying to do it all at once. Doctors want to check if it's safer for you, if it leads to more successful clearing of the blockage in the long run, and if it makes the whole experience less stressful and more comfortable for patients.

Key takeaways

Looks at a new two-step approach for difficult heart artery blockages (CTOs).
Aims to improve safety, success rates, and patient experience of the procedure.
Compares a planned two-stage intervention to the usual one-stage approach.
Participation involves two planned heart procedures and follow-up checks.
Open to adults with specific 'high-risk' heart artery blockages.
Your medical team will fully explain all aspects before you decide.

Who may be eligible?

To join this study, people must be able to understand the study and agree to take part in writing. They also need to be able to attend all the follow-up appointments and procedures.

The study is for adults (18 years and older) who have a particularly tricky type of long-term blockage in their heart arteries, known as a 'high-risk' CTO. These are specific kinds of blockages that doctors have identified as being especially challenging to treat.

However, some conditions would mean someone can't participate. This includes if your blockage isn't considered 'high-risk,' if the blockage is inside a stent that's already there, or if certain crucial arteries (like the main artery leading to the heart or a specific part of the right coronary artery) are blocked right at their origin. You also can't join if there's no good blood flow to the part of the heart usually supplied by this blocked artery, or if you can't take certain blood-thinning medicines, are pregnant, or have skin damage from previous radiation treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I at least 18 years old?
Do I have a 'high-risk' long-term blockage in a heart artery?
Am I able to attend follow-up appointments?
Can I take blood-thinning medication if prescribed?
Am I able to give written permission to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have the 'investment' procedure, which is the first step of trying to prepare the blockage. Then, at a later date, you would have the 'completion' PCI procedure to fully clear the blockage. Throughout the study, you would have regular check-ups and assessments to monitor your heart health, how you're feeling, and to see if the procedure has been successful. The full duration of your participation, including follow-up appointments, will be clearly explained by your medical team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a potentially safer and more effective way to treat your heart blockage, as well as a better overall patient experience. However, as with any medical procedure, there are potential risks involved, which your doctor will discuss in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Columbia University Medical Center/ NewYork Presbyterian Hospital
Verified postcode
New York, United States
Haukeland University Hospital
Verified postcode
Bergen, Norway
Golden Jubilee National Hospital
Verified postcode
Glasgow, United Kingdom
Bristol Health
Verified postcode
Bristol, United Kingdom
St George´s Hospital
Verified postcode
London, United Kingdom

Common questions

What is a CTO?

CTO stands for Chronic Total Occlusion. It's a type of severe blockage in one of your heart's arteries that has been completely blocked for at least three months.

What is PCI?

PCI stands for Percutaneous Coronary Intervention. It's a procedure where doctors use a thin tube (catheter) with a balloon and sometimes a stent to open up blocked heart arteries.

Why two steps instead of one?

The study is testing if doing the procedure in two shorter, planned steps, rather than one long one, is safer, more successful, and a better experience for patients with very difficult blockages.

Will I get normal medical care if I don't join?

Absolutely. Your decision to join or not join this study will not affect the standard medical care you receive for your heart condition.

Will this study use new medications?

This particular study focuses on a new approach to the PCI procedure itself, rather than testing new medications. However, you will still receive standard medications as part of your overall care.