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Physiology Assessment
FFRangio for Coronary Artery Disease (ALL-RISE Trial)
N/A
Recruiting
Led By Allen Jeremias, MD, MSc
Research Sponsored by CathWorks Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
ALL-RISE Trial Summary
This trial tests if a new approach to treating coronary artery disease is as good as the current one.
Who is the study for?
This trial is for adults over 18 with certain types of chest pain (CCS or NSTEACS) who have a blockage in their heart's arteries that's suitable for special tests to measure blood flow. They can't join if they're not right for these tests.Check my eligibility
What is being tested?
The study is looking at whether using FFRangio, a new way to assess blood flow in the coronary arteries during procedures, works as well as the standard pressure wire-guided method used during angioplasty.See study design
What are the potential side effects?
Possible side effects may include discomfort at the catheter insertion site, bleeding, allergic reactions to contrast dye used in imaging, and rare complications related to heart catheterization like artery damage.
ALL-RISE 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
MACE
Secondary outcome measures
All-Cause Mortality
Bleeding
Contrast Dose
+14 moreALL-RISE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FFRangioExperimental Treatment1 Intervention
FFRangio guided revascularization
Group II: Pressure wireActive Control1 Intervention
Pressure wire-based guided revascularization (FFR or NHPR)
Find a Location
Who is running the clinical trial?
Cardiovascular Research Foundation, New YorkOTHER
24 Previous Clinical Trials
25,106 Total Patients Enrolled
CathWorks Ltd.Lead Sponsor
3 Previous Clinical Trials
616 Total Patients Enrolled
Allen Jeremias, MD, MScPrincipal InvestigatorSt. Francis Hospital & Heart Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart valve problem on the left side.My heart's pumping ability is significantly reduced.I have had a successful heart bypass surgery.I had a severe heart attack within the last 3 days.I am being evaluated for heart bypass surgery.I am an adult with certain heart conditions and have a blockage in my heart's arteries suitable for specific tests.My heart has a damaged area due to a previous severe heart attack.I am not pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: FFRangio
- Group 2: Pressure wire
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.
Can any new participants still join this scientific trial?
"According to the details available on clinicaltrials.gov, this trial is not presently recruiting participants. First posted in June of 2023 and last updated at the end of May, there are currently 49 other medical studies actively searching for volunteers."
Answered by AI
At how many venues is this experiment currently taking place?
"The medical study is currently running in 6 different centres, including Palo Alto - VA (Palo Alto), Stanford University (Detroit) and Ascension St. John Hospital (Allentown). Additionally, there are 3 other sites participating in the research."
Answered by AI
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