FFRangio for Coronary Artery Disease

(ALL-RISE Trial)

Not currently recruiting at 60 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for guiding treatment in individuals with coronary artery disease, a condition where the heart's blood vessels narrow or become blocked. The study compares FFRangio, an imaging technique, to the standard pressure wire-guided approach to determine its effectiveness. FFRangio uses imaging to guide treatment decisions without pressure wires. Adults with significant but not overly severe narrowing of their heart arteries may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that FFRangio is safe for coronary artery disease treatment?

Research has shown that using FFRangio to guide treatment is generally safe and well-tolerated for people with coronary artery disease. Studies have found positive results one year after using FFRangio, with no major safety issues reported. Specifically, a study of early users of FFRangio technology showed good safety results over a year, indicating that serious side effects are rare.

Additionally, FFR (Fractional Flow Reserve) and NHPR (Non-Hyperemic Pressure Ratios) are common methods used to guide heart treatments and are considered safe. These methods help doctors decide if a narrowed artery needs treatment, and both have been widely studied with strong safety records.

Overall, the evidence supports the safe use of both FFRangio and pressure wire-guided methods in treating coronary artery disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FFRangio technique for coronary artery disease because it offers a non-invasive way to guide revascularization decisions. Traditional methods like pressure wire-based FFR require inserting a wire into the coronary artery, which can be uncomfortable and carries some risk. FFRangio, on the other hand, uses advanced imaging to assess blood flow without the need for a wire, potentially making the process safer and more comfortable for patients. This technique could streamline the decision-making process and improve patient outcomes by providing precise information quickly and non-invasively.

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

Research has shown that FFRangio-guided treatment works well for coronary artery disease (CAD). One study found that FFRangio, a non-invasive method, was 93.7% accurate in diagnosing CAD. Another study demonstrated that using FFRangio to guide treatment improved long-term outcomes for patients with CAD. In this trial, participants will be assigned to either the FFRangio-guided revascularization arm or the pressure wire-based guided revascularization arm. FFRangio matches the effectiveness of traditional techniques that use pressure wires but is less invasive. Overall, FFRangio has shown promising results in managing CAD, making it a strong alternative to conventional methods. ^{1 3 6 7 8}

Who Is on the Research Team?

Ajay J Kirtane, MD, SM

Principal Investigator

NewYork-Presbyterian/Columbia University Irving Medical Center

William F Fearon, MD

Principal Investigator

Stanford University

Allen Jeremias, MD, MSc

Principal Investigator

St. Francis Hospital & Heart Center

Martin B Leon, MD

Principal Investigator

NewYork-Presbyterian/Columbia University Irving Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jacc.org jacc.org/doi/10.1016/j.jcin.2021.11.039

Clinical Outcomes of FFRangio-Guided Treatment for ... We examined the 1-year clinical outcomes of FFRangio-guided treatment for CAD at 2 early-adopting centers of the FFRangio technology.

2. cath.works cath.works/wp-content/uploads/2018/08/Circ-Nov-2-2017.pdf

Clinical Outcomes and Cost-Effectiveness of Fractional ... CONCLUSIONS: PCI of lesions with reduced fractional flow reserve improves long-term outcome and is economically attractive compared with MT alone in patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10279845/

Current status and future perspectives of fractional flow ... Overall diagnostic accuracy for AccuFFRangio was 93.7% (22). These results were further confirmed in another trial performed in 298 patients/ ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05893498

Study Details | NCT05893498 | Advancing Cath Lab ... The ALL-RISE study is designed to test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with ...

5. cath.works cath.works/provision-study-meets-its-primary-endpoint/

PROVISION Study, First Ever Prospective RCT of ... The investigators shared the first randomized controlled trial (RCT) of FFRangio outcomes compared to invasive wire-based fractional flow ...

6. cath.works cath.works/cathworks-ffrangio/

Cathworks FFRangio One-year clinical outcomes of FFR angio-guided treatment of coronary artery disease, as presented at EuroPCR 2023. Regulatory Status. The CathWorks FFRangio ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03226262

NCT03226262 | FFRangio Accuracy vs. Standard FFR Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013844

Clinical Value of Single-Projection Angiography–Derived ... Our study aimed to evaluate the diagnostic accuracy of μFR and the safety of deferring non-IRA lesions with μFR >0.80 in the setting of AMI.