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WithdrawnNCT04566289PiCSO-AMI-IVUpdated Mar 8, 2023

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

An observational study in STEMI - ST Elevation Myocardial Infarction and Anterior MI, sponsored by Miracor Medical SA. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Miracor Medical SA · Observational

Why this study was withdrawn
Study terminated due to lack of financing
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.

Read the 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.

02

Conditions studied

  • STEMI - ST Elevation Myocardial Infarction
  • Anterior MI

Keywords

  • PiCSO
  • PiCSO Impulse System
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

Browse Myocardial Infarction studies →

Lead sponsor

Miracor Medical SA is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • PiCSO treatment group

    PiCSO treatment as per IFU

    Device: PiCSO

Interventions

  • DevicePiCSO

    Percutaneous coronary intervention

    Also known as: PCI

06

What researchers measure

Primary outcomes

  1. Adverse Device Effect (ADE) rate at 30 days post index procedure PCI

    Adverse Device Effect (ADE) rate at 30 days post index procedure PCI

    Time frame: 30 days

07

Study locations

1 site
  • Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
    Dresden, Germany
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04566289
Lead sponsor
Miracor Medical SA
Responsible party
Sponsor
First posted
Sep 28, 2020
Start date
Oct 1, 2022 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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