Firehawk Stent for Coronary Artery Disease
(TARGET-IV_NA Trial)
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.12345
How is the Firehawk stent treatment different from other treatments for coronary artery disease?
What data supports the effectiveness of the Firehawk stent treatment for coronary artery disease?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either the Firehawk® rapamycin eluting stent or a 2nd generation DES
Follow-up
Clinical follow-up to monitor safety and effectiveness, including angiographic and OCT assessments for sub-study participants
Angiographic and OCT Sub-study
Angiographic follow-up at 13 months for first 200 patients, with OCT for first 50 of these patients
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai MicroPort Medical (Group) Co., Ltd.
Lead Sponsor