Firehawk Stent for Coronary Artery Disease

(TARGET-IV_NA Trial)

Not currently recruiting at 58 trial locations

Overseen By Ming Zheng

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.

Must not be taking: Anticoagulants, Immunosuppressives

Disqualifiers: Recent STEMI, Cardiogenic shock, others

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

Compensation: Varies

Number of Visits: 32

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart stent called the Firehawk, which releases a drug to help keep arteries open. Researchers are comparing it to other stents already used for coronary artery disease, a condition where arteries supplying blood to the heart become narrowed. The goal is to determine if the Firehawk is as safe and effective as current stents, such as the 2nd generation drug-eluting stents (DES) from the XIENCE, Promus, Resolute/Onyx, Endeavor, and Orsiro families. Suitable candidates for this trial have experienced chest pain or heart issues due to narrowed heart arteries and have not had a recent severe heart attack. As an unphased trial, this study allows patients to contribute to important research that could improve future heart stent options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have an allergy to any trial-required medications or are on chronic oral anticoagulant treatment, you may not be eligible to participate.

What prior data suggests that the Firehawk stent is safe for treating coronary artery disease?

Research has shown that the Firehawk stent is safe for people. One study found it safe and effective over five years, with a low chance of blood clots forming. Another study found that after one year, the Firehawk stent was as safe and effective as the well-known XIENCE stent. A third study confirmed these results, showing that the Firehawk stent was as safe as other standard stents over five years.

Overall, these findings suggest that the Firehawk stent is well-tolerated with a relatively low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Firehawk stent is unique because it combines the benefits of a drug-eluting stent with a new, innovative design that targets coronary artery disease more effectively. Unlike traditional second-generation drug-eluting stents, which release medication from a coating on the stent's surface, the Firehawk stent uses a micro-groove design to release the drug precisely where it's needed, minimizing unnecessary exposure to surrounding tissue. This precision delivery aims to enhance healing and reduce the risk of complications like restenosis. Researchers are excited about the Firehawk stent because it represents a potential leap forward in stent technology, offering more targeted treatment and possibly better outcomes for patients with coronary artery disease.

What evidence suggests that the Firehawk Stent is effective for coronary artery disease?

Studies have shown that the Firehawk stent, which participants in this trial may receive, is safe and effective for heart patients. Research indicates that after one year, the Firehawk stent performs well, with a low complication rate, such as blood clots, at just 1.2%. Long-term data over five years demonstrate that the Firehawk stent is as effective and safe as other popular stents, such as those in the 2nd generation DES group, including the XIENCE. These findings suggest that the Firehawk stent is a reliable option for treating coronary artery disease. ^{1 2 3 5 6}

Who Is on the Research Team?

Martin Leon

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

Adults with coronary artery disease who need a stent and can follow the trial's procedures. They should have certain types of heart conditions like angina or recent heart attacks, but not be in immediate critical condition (like shock) or have had a very recent stent procedure. People with severe heart failure, planned surgeries, allergies to trial materials, other serious illnesses, or on certain medications cannot join.

Inclusion Criteria

My heart condition involves complex issues like calcified or twisted arteries.

It is likely that the study device can be safely placed in the target area of the heart.

Patient is willing to comply with all protocol-required follow-up evaluations

Exclusion Criteria

My heart condition requires two stents due to a bifurcation lesion.

My kidney function, measured by creatinine clearance, is low.

I am on immunosuppressive therapy or have an autoimmune disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the Firehawk® rapamycin eluting stent or a 2nd generation DES

Procedure day

1 visit (in-person)

Follow-up

Clinical follow-up to monitor safety and effectiveness, including angiographic and OCT assessments for sub-study participants

5 years

Visits at 30 days, 6 months, 1, 2, 3, 4, and 5 years

Angiographic and OCT Sub-study

Angiographic follow-up at 13 months for first 200 patients, with OCT for first 50 of these patients

13 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)
• Firehawk Stent

Trial Overview The trial is testing if the Firehawk rapamycin eluting stent system is as good as current second-generation drug-eluting stents for treating people with ischemic heart disease. It involves patients whose coronary arteries are of specific sizes and who may have complex lesions.

How Is the Trial Designed?

Group I: Firehawk group Experimental Treatment 1 Intervention

Participants implant Firehawk stent(s)

Group II: 2nd generation DES Active Control 1 Intervention

Participants implant Everolimus eluting stents (Xience family - Abbott Vascular, Promus family- Boston Scientific, Synergy - Boston Scientific), or Zotarolimus eluting stents (Resolute/Onyx family and Endeavor- Medtronic), or Sirolimus eluting stents (Orsiro- Biotronik)

Who Is Running the Clinical Trial?

Shanghai MicroPort Medical (Group) Co., Ltd.

Lead Sponsor

Trials

24

Recruited

19,600+

Citations

1. jacc.org jacc.org/doi/10.1016/S0735-1097%2824%2903083-3

ONE-YEAR CLINICAL OUTCOMES OF FIREHAWK™ ... Based on this study, which was carried out in a Brazilian unique center, the Firehawk™ stent was effective and safe at 12-months follow-up.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12097335/

One-year outcomes with the Firehawk sirolimus-eluting ... Although the results have shown noninferiority, a 1.2% rate of definitive thrombosis was observed throughout the 12-month follow-up, which could ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002914923013772

Long-Term Percutaneous Coronary Intervention Outcomes ... At 5 years, the FIREHAWK stent was as safe and effective as the XIENCE stent. ... The outcomes were not influenced by clinical presentation. In ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30565397/

Safety and efficacy of a novel abluminal groove-filled ... Conclusions: Five-year results demonstrate the continuing safety and efficacy of the FIREHAWK Stent, with relatively lower incidence of thrombotic events.

5. recintervcardiol.org recintervcardiol.org/en/scientific-letter/one-year-outcomes-with-the-firehawk-sirolimus-eluting-stent-and-biodegradable-polymer-guided-by-intravascular-ultrasound

One-year outcomes with the Firehawk sirolimus-eluting ... Although the results have shown noninferiority, a 1.2% rate of definitive thrombosis was observed throughout the 12-month follow-up, which could be related to ...

6. eurointervention.pcronline.com eurointervention.pcronline.com/article/targeted-therapy-with-a-localised-abluminal-groove-low-dose-sirolimus-eluting-biodegradable-polymer-coronary-stent-five-year-results-of-the-target-all-comers-randomised-clinical-trial

five-year results of the TARGET All Comers randomised ... TARGET-AC confirms that up to 5 years, the FIREHAWK BP-SES is as safe and effective as the well-established DP-EES in an all-comers population, as suggested in ...