Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance (PiCSO-AMI-IV)

August 23, 2022 updated by: Miracor Medical SA
A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a observational registry study. Patients with an ST-segment elevated anterior infarct eligible for PCI and commercial PiCSO treatment will be invited to participate in the PiCSO-AMI-IV study. After having given consent as per approved ethics committee requirements, the PCI of the culprit vessel should be performed per standard practices. After blood flow restoration, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS to start the PiCSO therapy. After the procedure the patient will be followed for safety assessments at 30 days, 6 months, 1 year, 2 year and 3 years post index procedure.

Study Type

Observational

Enrollment (Anticipated)

444

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Dresden, Germany
        • Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
        • Contact:
          • Axel Linke, Prof.

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will consist of subjects presenting with acute myocardial infarction, pre-PCI TIMI flow 0 or 1 and symptom duration ≤ 12 h who are eligible for primary percutaneous coronary intervention as per IFU.

Description

Inclusion Criteria:

  1. Age ≥18 years old
  2. Culprit lesion in proximal or mid LAD
  3. ST-segment elevation
  4. Pre-PCI TIMI flow 0 or 1.
  5. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h.
  6. Patient is deemed eligible for PCI
  7. Consent as per approved national ethical committee specific requirements prior to the procedure.

Exclusion Criteria:

  1. Patients with contraindications to percutaneous insertion or angiography
  2. Patients with implants or foreign bodies in the coronary sinus
  3. Known allergy to polyurethanes, PET or stainless steel
  4. Known pregnancy or breast feeding
  5. Known pericardial effusion or cardiac tamponade
  6. Known central hemodynamically relevant left/right shunt
  7. Patients with symptom onset > 12 hours
  8. Patients with previous CABG
  9. Patients with a history of stroke, TIA or reversible ischemic neurological deficit within last 6 month.
  10. Patients with coagulopathy
  11. Patients under judicial protection, legal guardianship or curatorship.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PiCSO treatment group
PiCSO treatment as per IFU
Device: PiCSO
Percutaneous coronary intervention
Other Names:
  • PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
Time Frame: 30 days
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
30 days

Collaborators and Investigators

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

Sponsor

Miracor Medical SA

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 (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIR-CIP 0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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