Prospective Data Collection of IVMRI Cases

NCT ID: NCT00558441

Last Updated: 2007-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Plaque Lipid Characterization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

IVMRI

Intervention Type DEVICE

Intra Vascular Magnetic Resonance Imaging

Interventions

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IVMRI

Intra Vascular Magnetic Resonance Imaging

Intervention Type DEVICE

Other Intervention Names

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Cathamaran

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TopSpin Medical

INDUSTRY

Sponsor Role lead

Principal Investigators

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William Wijns, Prof.

Role: PRINCIPAL_INVESTIGATOR

OLV Hospital

Locations

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Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Sharon Sax

Role: CONTACT

Phone: +972-54-6603112

Email: [email protected]

Facility Contacts

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Shmuel Banai, Prof.

Role: primary

Other Identifiers

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PCL-1.2-002

Identifier Type: -

Identifier Source: org_study_id