SPECTACL: SPECTroscopic Assessment of Coronary Lipid

NCT00330928 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-01-05

Study results available
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Summary

The purpose of this study is to evaluate a near-infrared (NIR) spectroscopy system that has been designed to identify the chemical composition of coronary artery plaques in patients undergoing a percutaneous coronary intervention (PCI).

Conditions

Interventions

DEVICE

Near Infrared Spectroscopy (NIRS) Imaging

Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.

DEVICE

intravascular ultrasound (IVUS)

Ultrasound coronary catheter is positioned on a guidewire that has been placed in the coronary artery.Ultrasound imaging provides structural information about the vessel wall and blockages contained. It takes approximately 5 minutes to prepare, position, and to collect data with the catheter.

Sponsors & Collaborators

  • Infraredx

    lead INDUSTRY

Principal Investigators

  • Sergio Waxman, MD · Lahey Clinic, Burlington, MA, USA

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-10-31
Completion
2008-10-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00330928 on ClinicalTrials.gov