TandemHeart to Reduce Infarct Size (TRIS Trial) (TRIS)

December 3, 2015 updated by: CardiacAssist, Inc.

A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size

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)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.

  1. ≥ 18 years of age
  2. Presents within 6 hours of acute MI symptoms
  3. Evidence of ST elevation
  4. First myocardial infarction
  5. Written informed consent

EXCLUSION CRITERIA

The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.

  1. Contraindications to antiplatelet/anticoagulation therapy
  2. History of blood disorders or active bleeding
  3. Renal dysfunction or failure
  4. Neurologic damage
  5. Cardiogenic shock
  6. History of cerebrovascular disease
  7. History of transfusion reaction
  8. Prior coronary artery bypass surgery
  9. Participation in another trial with an investigational drug or device
  10. Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TandemHeart System + PCI
TandemHeart System prior to percutaneous coronary intervention
Procedure: Percutaneous coronary intervention
Other Names:
  • PCI
Device: TandemHeart System
ACTIVE_COMPARATOR: PCI
Percutaneous coronary intervention
Procedure: Percutaneous coronary intervention
Other Names:
  • PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety
Time Frame: 30 days post-procedure

Major Adverse Cardiac or Cerebrovascular Events (MACCE):

  • Death, all cause
  • Stroke
  • Reinfarction
  • Major vascular complications
30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardiacAssist, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (ESTIMATE)

June 16, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA 2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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