All studies
Enrolling by invitationNAINTERVENTIONAL

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

Status
Enrolling by invitation
Phase
NA
Sponsor
Philips Clinical & Medical Affairs Global
Enrolment target
3,212
Start
17 Jun 2021
Estimated completion
01 Jun 2028

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.

  1. Are you an adult with chest pain or a recent heart attack (NSTEMI)?
  2. Are you having a heart catheterisation with a possible stent procedure planned?
  3. Do you have a significant blockage in at least one heart artery that needs treatment?
  4. Have you NOT had a recent severe heart attack (STEMI) or bypass surgery?
  5. Are you willing to attend all study visits and appointments?
Answer every question to see your result.

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

Taking part in this study could potentially offer you the benefit of receiving treatment guided by the latest technology, which may lead to a more precise and effective stent placement. However, as with any medical procedure, there are potential risks involved, such as bleeding, infection, or issues related to the procedure itself. These risks are generally similar to those associated with standard PCI procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (84)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama Birmingham
    Verified postcode
    Birmingham, United States
  • Pima Heart & Vascular
    Verified postcode
    Tucson, United States
  • Central Arkansas Veterans Healthcare System (CAVHS)
    Verified postcode
    Little Rock, United States
  • Glendale Adventist
    Verified postcode
    Glendale, United States
  • Colorado Heart and Vascular
    Verified postcode
    Lakewood, United States
  • Yale University
    Verified postcode
    New Haven, United States
  • MedStar Washington Hospital Center
    Verified postcode
    Washington D.C., United States
  • Memorial Healthcare
    Verified postcode
    Hollywood, United States
  • Tampa Cardiovascular Innovations and Research
    Verified postcode
    Tampa, United States
  • Emory University Hospital
    Verified postcode
    Atlanta, United States
  • Northeast Georgia Medical Center
    Verified postcode
    Gainesville, United States
  • Straub Medical Center
    Verified postcode
    Honolulu, 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?

Register your interest

Share your details and the research team for "Distal Evaluation of Functional Performance with Intravascul…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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