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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months and yearly thereafter until 5 years
Awards & highlights
TARGET-IV_NA Trial Summary
This trial is comparing the Firehawk stent to other currently approved stents to see if it is just as effective in treating subjects with ischemic heart disease.
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.Check my eligibility
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.See study design
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.
TARGET-IV_NA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My heart's artery blockage is between 2.25mm and 4.0mm wide and up to 44mm long.
TARGET-IV_NA Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
All-cause mortality
Any MI
Cerebral Revascularization
+12 moreTARGET-IV_NA 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)
Find a Location
Who is running the clinical trial?
Shanghai MicroPort Medical (Group) Co., Ltd.Lead Sponsor
23 Previous Clinical Trials
17,847 Total Patients Enrolled
15 Trials studying Coronary Artery Disease
13,203 Patients Enrolled for Coronary Artery Disease
Martin LeonStudy ChairColumbia University
1 Previous Clinical Trials
1,203 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I need to take blood thinners regularly.I am allergic to contrast dye, the trial's stent system, or any related medications or devices.I have a blockage in my blood vessel that might need a stent within a year.I had a procedure to open my heart's arteries within the last year.Your lesion needs more than three stents implanted.My heart condition involves complex issues like calcified or twisted arteries.I currently have an active peptic ulcer or am experiencing active bleeding.I had a heart procedure within the last 24 hours.I am currently on a breathing machine.My condition involves narrowed arteries from previous stent placements.Your heart's pumping function is very weak, less than 30%.It is likely that the study device can be safely placed in the target area of the heart.Your platelet count is too low (less than 100,000 cells/mm3) or too high (more than 700,000 cells/mm3).Planning to get pregnant within the next year.Your white blood cell count is less than 3,000 cells per cubic millimeter.I am 18 years old or older.I have a serious liver condition.I do not have any upcoming procedures that could interfere with the study.I have had an organ transplant or am waiting for one.I am scheduled for surgery within the next 6 months.I do not have a serious illness expected to shorten my life to under 2 years.My heart's artery blockage is between 2.25mm and 4.0mm wide and up to 44mm long.You have experienced a blood clot around a stent in the past.I have experienced a severe heart condition known as cardiogenic shock.Your hemoglobin level is less than 10 grams per deciliter.I have had a procedure on the main artery of my heart without a stent.My stent is longer than 36mm for small diameters.I had a severe heart attack within the last 24 hours, or my heart damage markers are still rising.I need a procedure to open blocked arteries due to chest pain or a recent heart attack.I do not have any health issues that would stop me from following the study rules.It is okay if you have more than one stent in place.
Research Study Groups:
This trial has the following groups:- Group 1: 2nd generation DES
- Group 2: Firehawk group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensively is this research study being conducted?
"Presently, 51 different medical facilities are recruiting patients for this trial. Examples of cities with a participating location include Birmingham, Santa Barbara and Indianapolis. To reduce the travel burden associated with enrollment, it is best to select the closest facility available."
Answered by AI
Is there an ongoing opportunity for individuals to become participants in this experiment?
"Affirmative. According to clinicaltrials.gov, the advertised medical trial commenced on February 17th 2021 and is presently enrolling participants. A total of 1,720 people are needed from 51 different sites for this study's completion."
Answered by AI
How many individuals are permissible in this medical experiment?
"This clinical trial necessitates 1720 eligible patients in order to properly complete. Potential participants can join from a variety of locations such as Cardiology PC at Birmingham, Alabama or Santa Barbara Cottage Hospital located in the state of Indiana."
Answered by AI
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