Firehawk Stent for Coronary Artery Disease

(TARGET-IV_NA Trial)

Recruiting at 56 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

1720 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new type of stent that releases a drug to keep heart arteries open in patients with certain types of heart disease. The goal is to see if it works as well as current treatments. Drug-eluting stents, which release drugs to prevent artery blockage, have shown promising results and are a major focus in cardiovascular medicine.

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.

Is the Firehawk Stent safe for use in humans?

The Firehawk Stent has been shown to have a safety profile comparable to the XIENCE stent, with no significant differences in major adverse events over a 5-year period. It is designed to reduce inflammation and hypersensitivity reactions, and no cases of stent thrombosis were reported in the Firehawk group during the 5-year follow-up. ^{1 2 3 4 5}

How is the Firehawk stent treatment different from other treatments for coronary artery disease?

The Firehawk stent is unique because it uses a biodegradable polymer that releases sirolimus, a drug that helps prevent artery blockage, from grooves on the stent's surface. This design aims to reduce long-term complications compared to traditional stents that use a permanent polymer. ^{2 3 4 6 7}

What data supports the effectiveness of the Firehawk stent treatment for coronary artery disease?

Research shows that the Firehawk stent is as effective and safe as the Xience V stent for treating coronary artery disease, with similar rates of complications and no cases of stent blockage over five years. ^{2 3 4 6 8}

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. France pubmed.ncbi.nlm.nih.gov

A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions]. [2018]

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

2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent. [2020]

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

Clinical outcomes of complex lesions treated with an abluminal groove-filled biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent. [2021]

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

Resolute Italian study in all comers: immediate and one-year outcomes. [2014]

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

The Firehawk Stent: A Review of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Device profile of the XIENCE V and XIENCE Sierra stents for the treatment of coronary artery disease: an overview of safety and efficacy. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial. [2018]