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

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

No Placebo Group

Breakthrough Therapy

Trial Summary

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.

Eligibility Criteria

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.

I am 18 years old or older.

+5 more

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.

+27 more

Participant Groups

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.

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)