Active not recruitingNAINTERVENTIONAL

The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)

This study, called The OCTOBER Trial, is looking into the best way to treat blockages in the heart's arteries, especially in complicated areas where an artery splits (called a bifurcation). People with ischemic heart disease often need a procedure to unblock these arteries and insert a stent, a small mesh tube that keeps the artery open. The trial compares two methods: one uses a standard X-ray guide, and the other uses a special internal scan called Optical Coherence Tomography (OCT) to guide the stent placement. Researchers want to see if using OCT helps people have better health outcomes, or fewer problems, over two years compared to the standard approach. It’s for adults aged 18 and over, of any gender, who need this type of heart procedure.

At a glance

Status

Active not recruiting

Phase

Sponsor

Aarhus University Hospital Skejby

Enrolment target

1,201

Start

05 Jul 2017

Estimated completion

01 May 2029

Ischaemic Heart Disease Ischemic Heart Disease

What is this study about?

When your heart arteries become narrowed or blocked, it's often due to a condition called ischemic heart disease. This can lead to chest pain (angina) or even a heart attack. One common treatment is a procedure to open the artery and place a small tube, called a stent, to keep it clear. Sometimes, these blockages happen in tricky spots where an artery splits into two branches – like a fork in the road. These are called 'bifurcation lesions' and can be more complex to treat.

This study, 'The OCTOBER Trial,' wants to find out the best way to put stents in these complicated areas. Normally, doctors use X-rays (angiography) to see inside the artery during the procedure. However, there's a newer technique that uses a special camera probe, called Optical Coherence Tomography (OCT), which gives doctors a very detailed, 3D view from inside the artery. This allows them to see things more clearly and make sure the stent is placed perfectly.

The main question of this study is whether using this advanced OCT scanning tool during the stenting procedure will lead to better health for patients over the next two years, compared to using the standard X-ray guidance. The researchers believe that the detailed information from OCT might help doctors place stents more accurately, potentially leading to fewer problems for patients in the long run. They are carefully comparing these two methods to see which one gives the best results.

Key takeaways

This study compares two ways of putting stents into heart arteries.
It focuses on complex blockages in areas where your artery splits.
One method uses standard X-ray guidance, the other uses a special internal scan (OCT).
The goal is to see if OCT guidance leads to better long-term health outcomes.
You would be followed for two years to monitor your progress.

Who may be eligible?

To be considered for this study, you would need to be 18 years or older and have certain types of heart artery blockages. These blockages need to be in a specific complex area where the artery splits, and both parts of the artery need to be certain sizes. You would also need to have symptoms like chest pain, or tests showing that your heart isn't getting enough blood flow because of these blockages. You must also be able to understand the study and agree to take part, and be willing to attend follow-up appointments.

There are also some reasons why you might not be able to join. For example, if you've had a very recent severe heart attack or are in heart failure, or have severe kidney problems or a short life expectancy. Also, if you have certain other serious health conditions or known allergies to the medicines or contrast dyes used in the procedure, you wouldn't be able to participate. The study also wouldn't be suitable if your artery blockages are in very twisty sections or involve completely blocked arteries that have been closed for a long time.

Quick self-check

Are you 18 years old or older?
Do you have chest pain or other signs of heart artery blockages?
Do your doctors plan to treat a complex blockage where an artery splits?
Do you have certain serious health conditions that would prevent you from taking part (e.g., severe kidney disease, very recent heart attack)?
Are you willing and able to attend follow-up appointments for two years?
Do you have any allergies to common heart medications or dyes?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you agree to take part in this study, you would be randomly assigned to receive one of two types of stent procedures for your heart arteries: either guided by standard X-ray imaging, or guided by a special internal scan called OCT. You wouldn't get to choose which method you receive. After your procedure, you would have regular follow-up appointments over two years. These appointments might involve clinic visits, phone calls, or questionnaires to check on your health and any symptoms you might have. You would continue to take any prescribed medications as normal. The total duration of your active participation in the study would be two years.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving the OCT-guided procedure, which some evidence suggests could lead to better stent placement. However, it's also possible that the standard method is just as good, or even better, and there are potential risks associated with any heart procedure, such as bleeding, infection, or complications from stenting. You will be closely monitored throughout the study. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (38)

Ziekenhuis Oost-Limburg (ZOL) Genk
Genk, Belgium
Leuven University Hospital
Leuven, Belgium
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital Skejby
Aarhus N, Denmark
Gentofte Hospital
Gentofte Municipality, Denmark
Rigshospitalet
København Ø, Denmark
Odense University Hospital
Odense, Denmark
Zealand University Hospital, Roskilde Sygehus
Roskilde, Denmark
Estonia Medical Centre
Tallinn, Estonia
Tampere University Hospital
Tampere, Finland
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Universitäres Herzzentrum Hamburg
Hamburg, Germany

+26 more sites — see the official record for the full list.

Common questions

What is 'ischemic heart disease'?

It's a common heart condition where your heart doesn't get enough blood flow, often because arteries are narrowed or blocked.

What is an 'OCT scan' and why is it used?

OCT (Optical Coherence Tomography) is a detailed internal scan that provides a very clear picture of your artery, helping doctors place stents more precisely.

Will I get to choose which treatment I receive?

No, you would be randomly assigned to either the standard X-ray guided procedure or the OCT-guided procedure, like flipping a coin for fairness.

How long will I be involved in the study?

You would be followed for two years after your procedure to check on your health and see how you're doing.

Are there any extra costs for participating?

No, there are no extra costs for participating in the study. Your medical care and the treatments would be provided as usual.