Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II

NCT06909578 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2402
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the CoFI system in detecting MVO in STEMI subjects, as confirmed by CMRI. The study will be conducted in accordance with the Declaration of Helsinki, EN ISO 14155:2020, local and national regulations. Each study site will receive support from a sponsor-certified proctor during the learning curve to ensure consistent and accurate application of the CoFI system.

Conditions

Microvascular Obstruction (MVO); STEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Primary Effectiveness Endpoint

  Diagnostic performance is measured by sensitivity and specificity of the CoFI system in detecting MVO in relation to the pre-set PCoFI threshold of 124 mmHg. The analysis will be per-protocol (PP) (primary) and the full analysis set (FAS) (secondary). Hypothesis Sensitivity and Specificity will be tested to meet the acceptance criteria: i.The lower bound of the confidence interval (CI) for sensitivity is 70% ii. The lower bound of the CI for specificity is 65% H0: p \< p0 H1: p ≥ p0 p0 = 70%se, 65%sp

  From enrollment to the end of treatment at 6 Months

Study Arms (1)

Adult subjects presenting with STEMI in the LAD undergoing PPCI

OTHER

Device: CorFlow Controlled Flow Infusion System - CoFI™

Interventions

CorFlow Controlled Flow Infusion System - CoFI™ DEVICE

The CorFlow CoFI™ System is intended to assess the dynamic microvascular resistance and to treat microvascular obstruction in the coronary vasculature of patients following PCI with stent placement.

Adult subjects presenting with STEMI in the LAD undergoing PPCI

Eligibility Criteria

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

You may qualify if:

• Clinical:
• Subject ≥18 years of age
• Ability to provide written informed consent according to GCP and governing regulations
• Diagnosis of acute anterior STEMI
• Persistent symptoms to balloon time ≤ 6 hours. The assessment by the treating investigator after evaluation by subjects explanation is the defining timepoint for symptom onset.
• PPCI \& Angiographic
• Culprit lesion in the LAD
• COFI ballon can be placed according to IFU
• Required stent diameter ≥ 2.75 mm and ≤ 5mm
• Required stent length ≥ 15 mm
• Successful PPCI Procedure as documented by \<50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow.

You may not qualify if:

• Clinical:
• Cardiogenic shock
• Thrombolytic therapy administered for this STEMI
• Contraindication to CMRI
• Cardiac pacemaker or implantable defibrillator;
• Non-MRI compatible aneurysm clip;
• Neural Stimulator (i.e., TENS unit);
• Any implanted or magnetically activated device (insulin pump);
• Any type of non-MRI compatible ear implant;
• Metal shavings in the orbits;
• Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
• Any history indicating contraindication to MRI
• Inability to follow breath hold instructions or to maintain a breath hold for \>15 seconds; and
• Known hypersensitivity or contraindication to gadolinium contrast.
• Subject with previous MI and/or known cardiomyopathy (ischemic and non ischemic), ventricular pseudoaneurysm, VSD, severe mitral valve regurgitation (with or without papillary muscle rupture), severe known cardiac valvular stenosis or insufficiency, pericardial disease

Sponsors & Collaborators

• CorFlow Therapeutics AG: lead

MeSH Terms

Conditions

ST Elevation 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

Central Study Contacts

Reginald D Walton, MBA

CONTACT

2544241252; rwalton@corflow.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share