PCI Revascularization Strategies for Coronary Artery Disease

Not currently recruiting at 54 trial locations

Overseen By Jolanda Pol-van der Velde, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Diagram B.V.

Disqualifiers: CABG, Severe valvular disease, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for performing a heart procedure called PCI (Percutaneous Coronary Intervention), which opens blocked arteries. One method combines two tests, FFR (Fractional Flow Reserve) and OCT (Optical Coherence Tomography), to guide the procedure, while the other uses FFR alone. The researchers aim to determine if using both tests leads to better outcomes for individuals with multiple blocked heart arteries. Suitable candidates have been diagnosed with at least two new blockages in different heart arteries that could be treated with PCI. As an unphased trial, this study allows patients to contribute to innovative research that could enhance heart procedures for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this PCI revascularization strategy is safe for patients with coronary artery disease?

Previous studies have shown that PCI, a procedure to open blocked heart arteries, using FFR, a method to measure blood flow, is safe. Patients who underwent PCI guided by FFR had a lower risk of death from any cause, indicating it is generally well-tolerated.

However, less information exists about using OCT, a special imaging technique, with FFR. OCT provides clearer views inside arteries, but long-term safety data is limited. While FFR-guided procedures are considered safe, researchers continue to study OCT to ensure it does not introduce additional risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for coronary artery disease because they refine how we decide on PCI revascularization strategies. Most current treatments for this condition use angiography alone to assess how blocked an artery is. However, the new approaches include either FFR (Fractional Flow Reserve) assessment alone or a combination of FFR and OCT (Optical Coherence Tomography) assessments. FFR helps measure blood pressure differences across a coronary artery to gauge the significance of a blockage, while OCT offers high-resolution images to evaluate the artery's condition. This combination could lead to more precise decision-making and potentially better outcomes for patients by tailoring treatment to the specific characteristics of their coronary artery disease.

What evidence suggests that this trial's PCI revascularization strategies could be effective for coronary artery disease?

This trial will compare two PCI revascularization strategies for coronary artery disease. One arm will use a strategy based on both FFR and OCT assessments. Research has shown that using both FFR and OCT during PCI can improve treatment outcomes, as FFR measures blood flow and OCT provides detailed images of the arteries. Studies have found that this combined approach is generally safe and aids doctors in making better decisions about restoring blood flow.

The other arm will use a PCI revascularization strategy based on FFR assessment alone, with a sham OCT. Using FFR alone in PCI has been linked to a lower risk of death in patients with coronary artery disease. Adding OCT provides more detailed information about the artery's condition, potentially leading to better results. Together, these methods aim to make PCI procedures more precise and effective. ^{6 7 8 9 10}

Who Is on the Research Team?

Elvin Kedhi, Prof.dr.

Principal Investigator

Professor of Medicine McGill University; Director Intervention Cardiology, McGill University Health Center, Canada; Visiting Professor, Silesian Medical University Katowice, Poland

Are You a Good Fit for This Trial?

This trial is for individuals aged 30-80 with multiple vessel coronary artery disease who are undergoing PCI. They must have at least two new blockages in different arteries suitable for PCI, as determined by a heart team. The blockages should be significant but the blood flow through them must still be normal.

Inclusion Criteria

I. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation)

I am between 30 and 80 years old and am having a PCI procedure.

I have at least 2 target lesions or 1 culprit and 1 target lesion for FFR.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PCI revascularization strategy based on combined FFR and OCT assessment or FFR-alone

12 weeks

Follow-up

Participants are monitored for cardiac death, myocardial infarction, or revascularization events

24 months

What Are the Treatments Tested in This Trial?

Interventions

• PCI revascularization strategy based FFR assessment
• PCI revascularization strategy based on combined FFR and OCT assessment

Trial Overview The COMBINE-INTERVENE Trial is testing if using both FFR (a pressure wire test) and OCT (an imaging test) to guide where stents should go during PCI is better than just using FFR alone in patients with multiple blocked arteries.

How Is the Trial Designed?

Group I: MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment Experimental Treatment 1 Intervention

MVD \> 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment

Group II: MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT) Placebo Group 1 Intervention

MVD \> 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)

Who Is Running the Clinical Trial?

Diagram B.V.

Lead Sponsor

Trials

15

Recruited

8,800+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Published Research Related to This Trial

In a study of 562 patients with acute myocardial infarction and multivessel disease, 30% of those undergoing angiography-guided PCI received unnecessary treatment for non-infarct-related arteries (non-IRA) that had a quantitative flow ratio (QFR) greater than 0.80, indicating they did not need intervention.

Patients who underwent unnecessary PCI for non-IRA lesions had a significantly higher rate of major adverse cardiac events (MACEs) at 12.9% compared to just 3.1% in those who deferred treatment, highlighting the risks associated with unnecessary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QFR Assessment and Prognosis After Nonculprit PCI in Patients With Acute Myocardial Infarction. Lee, SH., Hong, D., Shin, D., et al.[2023]

Citations

1. withpower.com withpower.com/trial/pci-revascularization-strategies-for-coronary-artery-disease-fb715

PCI Revascularization Strategies for Coronary Artery Disease Studies show that using FD-OCT and FFR in PCI procedures is generally safe, with no related cardiac adverse events reported during trials. These methods help ...

2. jacc.org jacc.org/doi/10.1016/j.jacasi.2025.08.015

Impact on Coronary Revascularization Decision Making This survey was designed to evaluate the impact of incremental information of coronary physiology and plaque vulnerability on revascularization ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10371824/

Fractional flow reserve use in coronary artery ... In patients with CAD undergoing coronary revascularization, FFR-guided PCI was associated with a lower risk of all-cause mortality, which is ...

4. ecrjournal.com ecrjournal.com/articles/tct-connect-2020-trial-update-forecast-combine-oct-ffr-and-define-pci?language_content_entity=en

FORECAST, COMBINE OCT-FFR and DEFINE-PCI The studies presented at TCT Connect 2020 add to the current evidence base for management of patients with epicardial CAD.

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.026960

Procedural Outcomes After Percutaneous Coronary ... PCI in vessels with focal disease defined by the PPG resulted in greater improvement in epicardial conductance and larger minimal stent area compared with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11269053/

PCI Deferral Based on Fractional Flow Reserve or Optical ... Safety of PCI deferral when FFR > 0.80 is known, while data on clinical outcomes using an OCT guidance are lacking. We assessed the safety of PCI deferral based ...

7. jacc.org jacc.org/doi/10.1016/j.jcin.2022.08.010

Optical Coherence Tomography Fractional Flow Reserve ... This study sought to investigate the relationship between post–percutaneous coronary intervention (PCI) OCT-FFR and long-term clinical outcomes in acute ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.124.014667

FFR-Negative Nonculprit High-Risk Plaques and Clinical ... This study aimed to assess the association between FFR-negative but high-risk nonculprit lesions and clinical outcomes.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2589004223013226

Fractional flow reserve use in coronary artery ... FFR-guided PCI as compared to non-physiology-guided coronary revascularization had lower risk of all-cause mortality (odds ratio [OR] 0.79 95% ...

10. nejm.org nejm.org/doi/full/10.1056/NEJMoa2201546

Fractional Flow Reserve or Intravascular Ultrasonography ... Procedures can be guided by fractional flow reserve (FFR) or intravascular ultrasonography (IVUS) for decision making regarding revascularization and stent ...