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

NCT04566289 | Withdrawn

• 1 other identifier: MIR-CIP 0004
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

STEMI - ST Elevation Myocardial Infarction; Anterior MI

Keywords

PiCSO; PiCSO Impulse System

Outcome Measures

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

  30 days

Study Arms (1)

PiCSO treatment group

PiCSO treatment as per IFU

Device: PiCSO

Interventions

PiCSO DEVICE

Percutaneous coronary intervention

Also known as: PCI

PiCSO treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Miracor Medical SA: lead

Study Sites (1)

Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden

Dresden, Germany

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Anterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 8, 2023

Record last verified: 2022-08

Locations

DE (1)