FFRangio for Coronary Artery Disease

(ALL-RISE Trial)

Recruiting at 56 trial locations

Overseen By Chi Chau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CathWorks Ltd.

Disqualifiers: STEMI, CABG, Severe valvular disease, others

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

Compensation: Varies

Number of Visits: 31

Duration: 1 day

1924 Participants Needed

Trial Summary

What is the purpose of this trial?

To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment FFRangio for Coronary Artery Disease?

Research shows that FFRangio, a non-invasive method to assess blood flow in the heart, is as accurate as the traditional invasive FFR method. It helps doctors make better decisions about heart procedures, potentially leading to better outcomes for patients with coronary artery disease. ^{1 2 3 4 5}

How does the FFRangio treatment for coronary artery disease differ from other treatments?

FFRangio is unique because it uses non-invasive coronary angiography to estimate fractional flow reserve (FFR), avoiding the need for a pressure wire and hyperemic drugs, which are required in traditional invasive FFR measurements. This makes it a safer and more convenient option for assessing coronary artery disease. ^{1 2 5 6 7}

Research Team

Allen Jeremias, MD, MSc

Principal Investigator

St. Francis Hospital & Heart Center

Martin B Leon, MD

Principal Investigator

NewYork-Presbyterian/Columbia University Irving Medical Center

Ajay J Kirtane, MD, SM

Principal Investigator

NewYork-Presbyterian/Columbia University Irving Medical Center

William F Fearon, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 with certain types of chest pain (CCS or NSTEACS) who have a blockage in their heart's arteries that's suitable for special tests to measure blood flow. They can't join if they're not right for these tests.

Inclusion Criteria

I am an adult with certain heart conditions and have a blockage in my heart's arteries suitable for specific tests.

Exclusion Criteria

I have a serious heart valve problem on the left side.

Patients with life expectancy <1 year as estimated by treating physician

My heart's pumping ability is significantly reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo FFRangio-guided or pressure wire-guided revascularization procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for major adverse cardiac events (MACE) and other outcomes

12 months

Multiple visits (in-person and virtual) at baseline, 30 days, and 12 months

Treatment Details

Interventions

• FFRangio
• FFR or NHPR

Trial Overview The study is looking at whether using FFRangio, a new way to assess blood flow in the coronary arteries during procedures, works as well as the standard pressure wire-guided method used during angioplasty.

Participant Groups

Group I: FFRangio Experimental Treatment 1 Intervention

FFRangio guided revascularization

Group II: Pressure wire Active Control 1 Intervention

Pressure wire-based guided revascularization (FFR or NHPR)

Who Is Running the Clinical Trial?

CathWorks Ltd.

Lead Sponsor

Trials

4

Recruited

2,500+

Cardiovascular Research Foundation, New York

Collaborator

Trials

28

Recruited

27,800+

References

1. United States pubmed.ncbi.nlm.nih.gov

Case Report of First Angiography-Based On-Line FFR Assessment during Coronary Catheterization. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Angiogram-Derived Fractional Flow Reserve: A Pooled Analysis of 5 Prospective Cohort Studies. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Invasive fractional flow reserve: Which technology is best? [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Why does FFR-guided PCI improve clinical outcomes? The missing link of post-PCI ischemia reduction. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of Fractional Flow Reserve Based on Computational Fluid Dynamics Modeling Using Coronary Angiographic Vessel Morphology Versus Invasively Measured Fractional Flow Reserve. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Diagnostic performance of angiography-derived fractional flow reserve in patients with NSTEMI. [2022]