Prospective Data Collection of IVMRI Cases (MIRACLE)

TopSpin Medical

Status: Unknown

Conditions: Coronary Plaque Lipid Characterization

Treatments: Device: IVMRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00558441

PCL-1.2-002

Details and patient eligibility

About

The study purpose is to prospectively collect data for a set of predefined variables in clinical cases where coronary plaque lipid characterization by IVMRI was performed during diagnostic or interventional procedures in order to gather incremental information beyond angiography and other diagnostic modalities.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An adult patient ≥ 18 years old.
• The patient, or legal guardian, has been informed of the nature of the study, agrees to its provisions, and has sign the approved informed consent.
• The patient and the treating physician agree to attend the follow-ups as defined in the study protocol.
• Indication for diagnostic and/or interventional procedure.
• Lesions in a native vessels where IVMRI interrogation may provide additional information beyond angiography and other diagnostic tools.

Exclusion criteria

• Culprit lesions within 48 hours following STEMI.
• Tortuous vessels, calcified or thrombotic lesions.
• Significant stenosis of an unprotected left main coronary artery.
• IVMRI interrogation of an unprotected left main coronary artery.
• Patients with pacemaker or cardioverter defibrillator.
• The patient is suffering from transplant mediated coronary artery disease.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

1

Experimental group

Treatment:

Device: IVMRI