Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting
This study is investigating a new way to help doctors decide how best to treat blocked heart arteries. Often, doctors use X-ray images (angiography) to see narrowed areas. This research compares that standard approach with a newer method. The new method uses tiny sensing wires (Philips pressure guidewires) that go inside your arteries to measure blood flow. This helps doctors see exactly how much a narrowing is affecting blood flow and, with a special system called SyncVision, guides them in placing small tubes (stents) to open up the artery. The goal is to find out if this more detailed, flow-guided approach can lead to better treatment outcomes for people with coronary artery disease, which causes chest pain and other heart issues.
At a glance
What is this study about?
Imagine your heart's arteries are like pipes that carry blood. Sometimes, these pipes can get narrowed or blocked, which can lead to chest pain or other heart problems. Doctors often fix this by putting in a small mesh tube called a stent to hold the artery open. This study is exploring the best way for doctors to guide where and how they place these stents.
Currently, doctors often use special X-rays, called an angiogram, to look at the arteries and decide where the narrowing is. This study compares that method with a more advanced technique. This new method uses very thin wires that can measure the actual blood flow and pressure inside your arteries. This gives doctors a more precise picture of how serious a narrowing is and whether it truly needs a stent. They then use a special system to match this information with the X-ray images, helping them guide the stent placement more accurately.
The main aim of this research is to see if using these advanced measurements to guide stent placement leads to better results for patients compared to using only the standard X-ray pictures. This could mean fewer future problems, better blood flow, and overall improved heart health for people with narrowed heart arteries.
Key takeaways
- This study compares two ways of guiding stent placement for blocked heart arteries.
- It uses a new technology with special wires to measure blood flow in arteries.
- The goal is to see if this new guidance leads to better patient outcomes.
- Participation involves your planned heart procedure and follow-up appointments.
- You can discuss with your doctor if this study is right for you.
Who may be eligible?
To join this study, you generally need to be an adult man or woman who is having a procedure called a cardiac catheterisation because you have chest pain, unstable angina, or a type of heart attack (NSTEMI). Your doctor must also think that a procedure to open up a blocked artery (called PCI) is needed in at least one of your heart arteries.
There are also certain reasons why you wouldn't be able to join. For example, if you've had a severe heart attack (STEMI) very recently, or if you've had a previous heart bypass surgery. You also can't participate if you've recently had a stent fitted or if your symptoms are only silent (meaning you don't feel them) and not related to coronary artery disease. Other reasons might include severe heart failure, very fast or irregular heartbeats that aren't controlled, or if you're in cardiogenic shock (a very serious heart condition).
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.
- Are you an adult with chest pain or a recent heart attack (NSTEMI)?
- Are you having a heart catheterisation with a possible stent procedure planned?
- Do you have a significant blockage in at least one heart artery that needs treatment?
- Have you NOT had a recent severe heart attack (STEMI) or bypass surgery?
- Are you willing to attend all study visits and appointments?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two groups: one where your stent procedure is guided by traditional X-ray pictures, or one where it's guided by the new pressure wire technology. Both procedures are designed to open up blocked heart arteries. The study will involve regular check-ups and tests, just like you would normally have after a heart procedure, to see how you're recovering and how well the treatment worked. The exact number of visits and tests will be explained to you in detail, but they are generally part of standard care. The total duration of your participation in the study will also be clearly outlined.
Potential risks and benefits
Locations (84)
- University of Alabama BirminghamVerified postcodeBirmingham, United States
- Pima Heart & VascularVerified postcodeTucson, United States
- Central Arkansas Veterans Healthcare System (CAVHS)Verified postcodeLittle Rock, United States
- Glendale AdventistVerified postcodeGlendale, United States
- Colorado Heart and VascularVerified postcodeLakewood, United States
- Yale UniversityVerified postcodeNew Haven, United States
- MedStar Washington Hospital CenterVerified postcodeWashington D.C., United States
- Memorial HealthcareVerified postcodeHollywood, United States
- Tampa Cardiovascular Innovations and ResearchVerified postcodeTampa, United States
- Emory University HospitalVerified postcodeAtlanta, United States
- Northeast Georgia Medical CenterVerified postcodeGainesville, United States
- Straub Medical CenterVerified postcodeHonolulu, United States
Common questions
What is PCI?
PCI stands for Percutaneous Coronary Intervention. It's a procedure where doctors use a tiny balloon and often a small mesh tube called a stent to open up blocked or narrowed heart arteries.
What is a 'pressure guidewire'?
It's a very thin wire that doctors can thread into your heart arteries. It has tiny sensors that measure blood flow and pressure, helping them understand how much a blockage is affecting your heart.
Will I know which treatment group I'm in?
Because this is a 'randomized' study, you'll be assigned to a group by chance, like flipping a coin. You might not know which method was used during your procedure, as this helps make the study results more reliable.
What happens if I change my mind about participating?
You are free to leave the study at any time, for any reason. Your decision will not affect the quality of medical care you receive.
Is this new technology safe?
The pressure guidewires and co-registration systems are already used in medical practice. This study aims to understand if using them to guide the PCI procedure makes a difference in patient outcomes.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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