Cardiac Catheterization for Coronary Artery Stenosis

Recruiting at 7 trial locations

Overseen By Arjun Bhat, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gentuity, LLC

Must not be taking: Vasodilators

Disqualifiers: STEMI, Sepsis, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial gathers crucial information on specific heart procedures using established technologies and drugs. It targets patients with suspected coronary artery disease, which involves narrowing or blockage of the heart's blood vessels. Participants will undergo tests such as angiography (imaging of blood vessels), FFR (a pressure wire test to assess blood flow), and HF-OCT (a detailed heart imaging technique) to evaluate their heart health. Individuals dealing with suspected coronary artery disease and scheduled for heart diagnostics might be suitable candidates. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants the opportunity to contribute to the validation of potentially groundbreaking treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that these cardiac catheterization technologies and drugs are safe?

Previous studies have shown that angiography has been safely used in many patients. This procedure involves taking X-ray images of blood vessels. Research indicates that while there is some risk, it is generally considered safe as part of standard medical procedures.

For the FFR (Fractional Flow Reserve) Pressure Wire, studies found that serious problems during the hospital stay were rare, occurring in about 3.3% of cases. Over time, patients who underwent this procedure experienced good outcomes.

HF-OCT (High-Frequency Optical Coherence Tomography) Imaging has also been studied. This technology uses light waves to take detailed pictures of blood vessels. Research indicates that it is safe and effective for guiding heart procedures.

Overall, all three technologies—angiography, FFR Pressure Wire, and HF-OCT Imaging—are well-tolerated and have been safely used in many medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these techniques because they offer a more detailed and precise assessment of coronary artery disease. Unlike traditional methods, angiography combined with FFR (Fractional Flow Reserve) pressure wire and HF-OCT (High-Frequency Optical Coherence Tomography) imaging provides real-time, high-resolution insights into coronary blood flow and vessel structure. FFR helps determine the exact impact of a blockage on blood flow, while HF-OCT offers a closer look at the vessel walls than ever before. This combination allows doctors to tailor treatments more accurately, potentially leading to better outcomes for patients undergoing procedures like PCI (Percutaneous Coronary Intervention).

What evidence suggests that this trial's treatments could be effective for cardiac catheterization?

This trial will evaluate different technologies used during procedures for opening blocked heart arteries (PCI). Research has shown that angiography, one of the technologies in this trial, can lower the risk of major heart problems and improve outcomes for patients with complex heart issues. Studies have found that another technology, FFR (Fractional Flow Reserve), leads to better results than angiography alone, reducing the chances of death and heart attacks. HF-OCT (High-Frequency Optical Coherence Tomography), also part of this trial, provides detailed images of the heart's arteries, aiding doctors in performing these procedures more safely and effectively. Evidence supports these technologies in improving heart health during treatments. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients provide written informed consent.

Clinical presentation consistent with suspected coronary disease.

Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Collection of angiography images, HF-OCT images, and FFR pressure wire data during a single catheterization laboratory visit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Angiography
• FFR Pressure Wire
• HF-OCT Imaging

How Is the Trial Designed?

Group I: Candidates for PCI Experimental Treatment 3 Interventions

Patients undergoing diagnostic cardiac catheterization/PCI.

Who Is Running the Clinical Trial?

Gentuity, LLC

Lead Sponsor

Trials

4

Recruited

510+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.117.031907

Clinical Outcomes and Cost-Effectiveness of Fractional ... Previous studies found that percutaneous coronary intervention (PCI) does not improve outcome compared with medical therapy (MT) in patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12546242/

Impact of percutaneous coronary intervention with different ... The clinical outcomes included major adverse cardiovascular events (MACE), all-cause mortality, cardiac death, myocardial infarction, and target ...

3. jacc.org jacc.org/doi/10.1016/j.jcin.2017.08.051

Clinical Outcomes Following Intravascular Imaging-Guided ... PCI guidance using either IVUS or OCT was associated with a significant reduction of major adverse cardiovascular events (OR: 0.79; 95% CrI: ...

4. bmj.com bmj.com/content/383/bmj-2023-077848

Intravascular imaging guided versus coronary angiography ... Intravascular imaging guided percutaneous coronary intervention was associated with significantly reduced cardiac death and cardiovascular outcomes.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2216607

Intravascular Imaging–Guided or Angiography-Guided ... Among patients with complex coronary-artery lesions, intravascular imaging–guided PCI led to a lower risk of a composite of death from cardiac causes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36373421/

Safety and efficiency of percutaneous coronary intervention ... Outcomes included procedure time, radiation exposure, contrast volume, device utilisation, and treatment strategy. Results: Compared with ...

7. jacc.org jacc.org/doi/full/10.1016/S0735-1097%2825%2901323-3

A SYSTEMATIC REVIEW AND META-ANALYSIS OF ... OCT was associated with superior clinical outcomes compared to angiography-guided PCI, especially in terms of MACE, cardiac death, and stent ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031111

Intravascular Imaging–Guided Versus Angiography ... Across all patients, intravascular imaging–guided PCI conferred a lower risk of cardiac death compared with angiography‐guided PCI (RR, 0.49 [95 ...

9. eurointervention.pcronline.com eurointervention.pcronline.com/article/safety-and-efficiency-of-percutaneous-coronary-intervention-using-a-standardised-optical-coherence-tomography-workflow

Safety and efficiency of percutaneous coronary intervention ... This study evaluated whether implementing a standardised pre-PCI and post-PCI OCT imaging workflow impacts PCI procedural safety and efficiency metrics ...