What is the mechanism of action of this treatment?

Common treatments for Coronary Artery Disease (CAD) include drug-eluting stents like the Firehawk® rapamycin eluting stent system, which releases rapamycin to inhibit cell proliferation and reduce restenosis, thereby maintaining vessel patency. Antiplatelet agents, such as aspirin and ticagrelor, prevent platelet aggregation and thrombus formation, reducing the risk of heart attacks. Statins lower LDL cholesterol levels, slowing the progression of atherosclerosis. Beta-blockers reduce heart rate and myocardial oxygen demand, alleviating symptoms and improving survival. These treatments are crucial for CAD patients as they address different aspects of the disease, from preventing vessel re-narrowing to reducing the risk of acute cardiovascular events.

What side effects are associated with this type of intervention?

Common treatments for Coronary Artery Disease (CAD) include drug-eluting stents (DES) like the Firehawk® rapamycin eluting stent system. These stents release medications such as rapamycin to inhibit cell proliferation and reduce restenosis. Known side effects of rapamycin and similar mTOR inhibitors include an increased risk of infections, delayed wound healing, and potential renal dysfunction. Additionally, patients may experience side effects related to the stent placement itself, such as bleeding, blood clots, and allergic reactions to the stent material or the drug coating.

What prior FDA approvals exist?

The FDA has approved several drug-eluting stents (DES) for the treatment of Coronary Artery Disease (CAD). These stents are designed to release medication that inhibits cell proliferation and reduces restenosis. Notable examples include the Cypher® stent, which releases sirolimus (rapamycin), and the Taxus® stent, which releases paclitaxel. Second-generation DES, such as the Xience® stent, release everolimus, and the Resolute® stent, which releases zotarolimus, have also been approved. These stents have shown improved safety and efficacy profiles compared to earlier versions.

What other types of research exist?

Promising novel alternatives to the Firehawk® rapamycin eluting stent system for CAD patients include: 1) Second-generation drug-eluting stents (DES) such as the Xience™ (everolimus-eluting) and Resolute™ (zotarolimus-eluting) stents, which have shown improved safety and efficacy profiles. 2) Bioabsorbable stents like the Absorb™ GT1 Bioresorbable Vascular Scaffold, which gradually dissolve and reduce long-term complications. 3) Drug-coated balloons (DCB) that deliver antiproliferative drugs directly to the vessel wall without leaving a permanent implant, such as the SeQuent® Please DCB. These alternatives offer various benefits, including reduced restenosis rates and improved long-term outcomes.

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Drug-Eluting Stent

Firehawk Stent for Coronary Artery Disease (TARGET-IV_NA Trial)

N/A

Waitlist Available

Research Sponsored by Shanghai MicroPort Medical (Group) Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.25 mm to ≤4.0 mm and up to 44 mm in length

Must not have

Bifurcation lesions with intended dual stent implantations

Subject is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months and yearly thereafter until 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the stents could include reactions at the implant site, bleeding complications, blood vessel re-narrowing around the stent area (restenosis), blood clots within the stent (thrombosis), and general risks associated with angioplasty procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My heart's artery blockage is between 2.25mm and 4.0mm wide and up to 44mm long.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am on immunosuppressive therapy or have an autoimmune disease.

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I need to take blood thinners regularly.

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I am allergic to contrast dye, the trial's stent system, or any related medications or devices.

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I have a blockage in my blood vessel that might need a stent within a year.

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I currently have an active peptic ulcer or am experiencing active bleeding.

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I had a heart procedure within the last 24 hours.

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I am currently on a breathing machine.

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My condition involves narrowed arteries from previous stent placements.

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I have a serious liver condition.

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I have had an organ transplant or am waiting for one.

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I am scheduled for surgery within the next 6 months.

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I do not have a serious illness expected to shorten my life to under 2 years.

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I have experienced a severe heart condition known as cardiogenic shock.

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I have had a procedure on the main artery of my heart without a stent.

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My stent is longer than 36mm for small diameters.

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I had a severe heart attack within the last 24 hours, or my heart damage markers are still rising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months and yearly thereafter until 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months and yearly thereafter until 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and yearly thereafter until 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

All-cause mortality

Any MI

Cerebral Revascularization

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Firehawk groupExperimental Treatment1 Intervention

Participants implant Firehawk stent(s)

Group II: 2nd generation DESActive Control1 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)

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronary Artery Disease (CAD) include drug-eluting stents like the Firehawk® rapamycin eluting stent system, which releases rapamycin to inhibit cell proliferation and reduce restenosis, thereby maintaining vessel patency. Antiplatelet agents, such as aspirin and ticagrelor, prevent platelet aggregation and thrombus formation, reducing the risk of heart attacks. Statins lower LDL cholesterol levels, slowing the progression of atherosclerosis. Beta-blockers reduce heart rate and myocardial oxygen demand, alleviating symptoms and improving survival. These treatments are crucial for CAD patients as they address different aspects of the disease, from preventing vessel re-narrowing to reducing the risk of acute cardiovascular events.