A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease (NightHawk)

January 16, 2008 updated by: FoxHollow Technologies
To assess the proximity of the catheter to the vessel wall and to correlate excised tissue with images collected by the integrated Optical coherence Tomography (OCT) imaging system. The primary endpoints are correlation between OCT images and histological characterization of excised tissue.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient requires treatment for peripheral arterial disease (PAD).
  2. Patient is willing and able to provide Informed Consent.
  3. Patient has at least one focal, de novo infrainguinal lesion in a native vessel.
  4. The minimum reference vessel diameter is 2.0 - 4.5 mm, dependent on the NightHawk device used.
  5. The lesion is ≥ 50% stenosed by quantitative vascular angiography.
  6. The lesion is ≤ 7 cm in length.
  7. The patient must be able to take at least one form of anti-platelet or anti-thrombotic therapy.

Exclusion Criteria:

  1. Patient presents with degree of limb disease or a co-existing medical condition that makes revascularization inappropriate.
  2. The patient has diffuse peripheral arterial disease and/or the disease is heavily calcified.
  3. Patient presents with concomitant disease contraindicating an endovascular intervention.
  4. Patient is pregnant.
  5. The patient has a hypersensitivity to contrast materials that cannot be adequately pretreated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (Estimate)

August 15, 2007

Study Record Updates

Last Update Posted (Estimate)

January 18, 2008

Last Update Submitted That Met QC Criteria

January 16, 2008

Last Verified

January 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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