Study Stopped
No participants enrolled
TandemHeart to Reduce Infarct Size (TRIS Trial)
TRIS
A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size
1 other identifier
interventional
N/A
0 countries
N/A
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 16, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedDecember 4, 2015
December 1, 2015
1.6 years
June 12, 2014
December 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Safety
Major Adverse Cardiac or Cerebrovascular Events (MACCE): * Death, all cause * Stroke * Reinfarction * Major vascular complications
30 days post-procedure
Study Arms (2)
TandemHeart System + PCI
EXPERIMENTALTandemHeart System prior to percutaneous coronary intervention
PCI
ACTIVE COMPARATORPercutaneous coronary intervention
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Presents within 6 hours of acute MI symptoms
- Evidence of ST elevation
- First myocardial infarction
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2014
First Posted
June 16, 2014
Study Start
January 1, 2015
Primary Completion
August 1, 2016
Study Completion
February 1, 2017
Last Updated
December 4, 2015
Record last verified: 2015-12