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Device
Enhancing PCI in STEMI for Seniors
N/A
Waitlist Available
Led By David F Kong, MD
Research Sponsored by David Kong, M.D.
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
No Placebo-Only Group
Summary
This trial is studying four potential advances in care for seniors with a heart attack. The hope is that these changes will improve outcomes for these patients.
Eligible Conditions
- Heart Attack
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adjudicated 1-year Complete versus Lesion-only Primary PCI trial (CvLPRIT) MACE
Adjudicated 1-year infarct-related artery Major Adverse Cardiac and Cerebrovascular Event (MACE)
Primary Observational Endpoint - Estimate of the incidence rate of Radial Artery Occlusion (RAO)
Secondary study objectives
Adjudicated Academic Research Consortium (ARC) definite stent thrombosis
Adjudicated Academic Research Consortium (ARC) definite/probable stent thrombosis
Adjudicated Cardiac Death
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Multi-vessel Disease, Culprit Vessel OnlyExperimental Treatment4 Interventions
Subjects randomized to revascularization of infarct related artery only. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
Group II: Multi-vessel Disease, Complete RevascularizationExperimental Treatment5 Interventions
Subjects randomized to complete revascularization. Complete revascularization of all diseased arteries with Medtronic Resolute family of stents; Use of Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology to determine which arteries to stent; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
Group III: Single Vessel DiseaseActive Control4 Interventions
Standard of care comparator for those subjects with single vessel coronary artery disease. Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
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Who is running the clinical trial?
Terumo Medical CorporationIndustry Sponsor
24 Previous Clinical Trials
10,000 Total Patients Enrolled
David Kong, M.D.Lead Sponsor
Medtronic VascularIndustry Sponsor
66 Previous Clinical Trials
57,039 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have multiple blocked blood vessels, as seen in an angiogram.You have medical conditions that would make it difficult to insert a tube through the wrist artery.You have severe shock and need special support for your heart or kidneys.You have blockage in only one blood vessel in your heart.You have a blockage in the main artery of your heart that is not protected by a stent or bypass surgery.You have blockages in one or more major heart arteries.You recently had a specific type of heart attack or a certain heart condition shown on an ECG, with chest pain lasting less than 12 hours.The doctor plans to perform a procedure called trans-radial PCI.You are suitable for receiving a drug-eluting stent.You need to have a clear and accessible artery in your right or left wrist for a specific heart procedure.You have a medical condition that makes it more risky for you to use IFR.You have had a stroke or mini-stroke in the past 6 months.You have a history of using drugs or alcohol that might make it hard for you to follow the study rules.You have a medical condition that is expected to significantly shorten your lifespan.
Research Study Groups:
This trial has the following groups:- Group 1: Multi-vessel Disease, Complete Revascularization
- Group 2: Multi-vessel Disease, Culprit Vessel Only
- Group 3: Single Vessel Disease
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.
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