Your session is about to expire
← Back to Search
Drug Eluting Stent
Drug-Eluting Stent for Coronary Artery Disease (SPIRIT 48 Trial)
N/A
Waitlist Available
Led By Ki E Park, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must be at least 18 years of age
Subject must have evidence of myocardial ischemia suitable for non-emergent PCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
SPIRIT 48 Trial Summary
This trial is evaluating the safety and effectiveness of a new type of coronary artery stent in people with CAD.
Who is the study for?
This trial is for adults with coronary artery disease due to long lesions, who have symptoms of reduced blood flow to the heart and are suitable for non-emergency stent placement. They must be able to undergo bypass surgery if needed, have a specific artery size, and commit to not joining other studies for a year. Exclusions include living outside the US, allergies to certain medications or device materials, recent heart attacks or procedures on the same vessel, pregnancy plans within a year after procedure, severe health conditions like cancer not in remission or major organ failure.Check my eligibility
What is being tested?
The SPIRIT 48 study tests the safety and effectiveness of ABT NG DES 48mm stents in improving blood vessel diameter in patients with long lesions in their coronary arteries. Participants will receive this new type of drug-eluting stent designed specifically for longer arterial blockages.See study design
What are the potential side effects?
Potential side effects may include reactions at the site where the stent is placed such as pain or bleeding; allergic reactions to stent material; clot formation leading to heart attack or stroke; narrowing of treated arteries over time; irregular heartbeat; infection risk from invasive procedure.
SPIRIT 48 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...
I have heart issues that can be treated with a planned procedure.
Select...
I am a suitable candidate for heart bypass surgery.
Select...
I have a specific type of blockage in my heart's artery.
Select...
My lesion is between 32 mm and 44 mm and can be treated with one device.
Select...
My heart's artery is more than half but not completely blocked, and blood flow is somewhat maintained.
SPIRIT 48 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Kaplan-Meier Estimate of 1-Year Target Lesion Failure (TLF)
Secondary outcome measures
Number of Participants With Target Lesion Failure (TLF)
SPIRIT 48 Trial Design
1Treatment groups
Experimental Treatment
Group I: ABT NG DES 48 EECSSExperimental Treatment1 Intervention
Participants will receive ABT NG DES 48 EECSS device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABT NG DES 48 EECSS
2020
N/A
~110
Find a Location
Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
404,081 Total Patients Enrolled
102 Trials studying Coronary Artery Disease
126,198 Patients Enrolled for Coronary Artery Disease
Ki E Park, MDPrincipal InvestigatorUniversity of Florida/Malcom Randall VAMC
Chi-Jen Chang, MDPrincipal InvestigatorChang Gung Memorial Hospital
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
150 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or react badly to aspirin, heparin, bivalirudin, or P2Y12 inhibitors.My heart's artery is more than half but not completely blocked, and blood flow is somewhat maintained.My lesion is between 32 mm and 44 mm and can be treated with one device.I have had or will have radiation therapy targeting a heart artery.Your platelet count is either too low (less than 100,000 cells/mm^3) or too high (more than 700,000 cells/mm^3).My kidney function is very low or I am on dialysis.I will need surgery that requires stopping aspirin or P2Y12 inhibitors within a year.I had a heart attack within 2 days before my scheduled procedure.You are allergic to the materials used in the device.I had a procedure to open my heart's arteries within the last year.I need a stent or bypass surgery after my initial heart procedure.I am 18 years old or older.You are not expected to live more than 2 years.The blood vessel being studied should be between 2.5 and 4.25 millimeters wide, as estimated by looking at it.My cancer is active and not in remission.I am on immunosuppressant therapy or have a severe autoimmune disease.I am at high risk of bleeding.I have had a stroke or a mini-stroke in the last 6 months.I have severe blood vessel disease that makes certain medical procedures unsafe for me.I have heart issues that can be treated with a planned procedure.I am a suitable candidate for heart bypass surgery.I have had a heart or peripheral artery procedure in the last 30 days.Your heart's pumping ability (LVEF) is less than 30% within the last 3 months.You are likely to need mechanical heart support during the procedure.I have had symptoms or a positive test for COVID-19 or a similar infection in the last 2 months.I have a specific type of blockage in my heart's artery.I have had a successful organ transplant or am waiting for one.
Research Study Groups:
This trial has the following groups:- Group 1: ABT NG DES 48 EECSS
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.
Is enrollment for this medical trial available at the moment?
"According to clinicaltrials.gov, this trial has already concluded its recruitment phase as the most recent update was posted on March 28th 2022. The study first launched June 17th 2020. Fortunately, there are 573 alternative trials actively searching for participants at present."
Answered by AI
How many US-based medical facilities have been authorized to conduct this investigation?
"Presently, this clinical trial is recruiting from 24 sites spread across the globe. Rome, Anderson and Scottsdale are some of these locations. To reduce travel requirements, it's prudent to choose a location closest to you if you plan on participating in the study."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger