STEMI - ST Elevation Myocardial InfarctionPiCSO-AMI-IVNCT04566289
Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
An observational study of STEMI - ST Elevation Myocardial Infarction and Anterior MI, run by Miracor Medical SA at 1 site in Germany.
Trial summary
A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Anterior MI
- What is being tested?
- PiCSO
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2022to 31 Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years old
- Culprit lesion in proximal or mid LAD
- ST-segment elevation
- Pre-PCI TIMI flow 0 or 1.
- Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h.
- Patient is deemed eligible for PCI
- Consent as per approved national ethical committee specific requirements prior to the procedure.
Who cannot join
- Patients with contraindications to percutaneous insertion or angiography
- Patients with implants or foreign bodies in the coronary sinus
- Known allergy to polyurethanes, PET or stainless steel
- Known pregnancy or breast feeding
- Known pericardial effusion or cardiac tamponade
- Known central hemodynamically relevant left/right shunt
Show all 11Show fewer
- Patients with symptom onset > 12 hours
- Patients with previous CABG
- Patients with a history of stroke, TIA or reversible ischemic neurological deficit within last 6 month.
- Patients with coagulopathy
- Patients under judicial protection, legal guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
Dresden
About this study
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.
- Being tested
- PiCSO
- Keywords
- PiCSO, PiCSO Impulse System
- Medical subject headings
- ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCSODevice
Also called PCI
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| PiCSO treatment group | PiCSO treatment as per IFU Receives: Device: PiCSO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Oct 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Study terminated due to lack of financing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Miracor Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566289
- Sponsor's protocol ID
- MIR-CIP 0004
- Acronym
- PiCSO-AMI-IV
- Status last verified
- Aug 2022
- First submitted
- 22 Sep 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
- ClinicalTrials.gov ID
- NCT04566289
- Acronym / sponsor ID
- PiCSO-AMI-IV / MIR-CIP 0004
- Keywords
- PiCSO, PiCSO Impulse System
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study terminated due to lack of financing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Miracor Medical SAIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PiCSO treatment group | – | Device: PiCSOPiCSO treatment as per IFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Age ≥18 years old
- Culprit lesion in proximal or mid LAD
- ST-segment elevation
- Pre-PCI TIMI flow 0 or 1.
- Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h.
Key exclusion criteria (11 listed)
- Patients with contraindications to percutaneous insertion or angiography
- Patients with implants or foreign bodies in the coronary sinus
- Known allergy to polyurethanes, PET or stainless steel
- Known pregnancy or breast feeding
- Known pericardial effusion or cardiac tamponade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiCSOAlso: PCIPercutaneous coronary intervention | Device | PiCSO treatment group |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for STEMI - ST Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST Elevation Myocardial Infarction and Anterior MI, run by Miracor Medical SA at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.