TandemHeart to Reduce Infarct Size (TRIS Trial) (TRIS)
Primary Purpose
Acute Myocardial Infarction
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TandemHeart System
Percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Myocardial infarction, STEMI, ST elevation MI, Acute MI
Eligibility Criteria
INCLUSION CRITERIA
The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.
- ≥ 18 years of age
- Presents within 6 hours of acute MI symptoms
- Evidence of ST elevation
- First myocardial infarction
- Written informed consent
EXCLUSION CRITERIA
The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.
- Contraindications to antiplatelet/anticoagulation therapy
- History of blood disorders or active bleeding
- Renal dysfunction or failure
- Neurologic damage
- Cardiogenic shock
- History of cerebrovascular disease
- History of transfusion reaction
- Prior coronary artery bypass surgery
- Participation in another trial with an investigational drug or device
- Pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TandemHeart System + PCI
PCI
Arm Description
TandemHeart System prior to percutaneous coronary intervention
Percutaneous coronary intervention
Outcomes
Primary Outcome Measures
Primary Safety
Major Adverse Cardiac or Cerebrovascular Events (MACCE):
Death, all cause
Stroke
Reinfarction
Major vascular complications
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02164058
Brief Title
TandemHeart to Reduce Infarct Size (TRIS Trial)
Acronym
TRIS
Official Title
A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardiacAssist, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction [STEMI]) by evaluating the use of the TandemHeart system prior to a procedure called percutaneous coronary intervention (PCI)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Myocardial infarction, STEMI, ST elevation MI, Acute MI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TandemHeart System + PCI
Arm Type
Experimental
Arm Description
TandemHeart System prior to percutaneous coronary intervention
Arm Title
PCI
Arm Type
Active Comparator
Arm Description
Percutaneous coronary intervention
Intervention Type
Device
Intervention Name(s)
TandemHeart System
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Other Intervention Name(s)
PCI
Primary Outcome Measure Information:
Title
Primary Safety
Description
Major Adverse Cardiac or Cerebrovascular Events (MACCE):
Death, all cause
Stroke
Reinfarction
Major vascular complications
Time Frame
30 days post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA
The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.
≥ 18 years of age
Presents within 6 hours of acute MI symptoms
Evidence of ST elevation
First myocardial infarction
Written informed consent
EXCLUSION CRITERIA
The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.
Contraindications to antiplatelet/anticoagulation therapy
History of blood disorders or active bleeding
Renal dysfunction or failure
Neurologic damage
Cardiogenic shock
History of cerebrovascular disease
History of transfusion reaction
Prior coronary artery bypass surgery
Participation in another trial with an investigational drug or device
Pregnant
12. IPD Sharing Statement
Learn more about this trial
TandemHeart to Reduce Infarct Size (TRIS Trial)
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