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

This study has been terminated.
(Other)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516308
First Posted: August 15, 2007
Last Update Posted: January 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FoxHollow Technologies
  Purpose
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.

Condition Intervention Phase
Peripheral Vascular Diseases Device: NightHawk Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by FoxHollow Technologies:

Estimated Enrollment: 100
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516308


Locations
United States, Texas
Austin Heart
Austin, Texas, United States, 78756
Sponsors and Collaborators
FoxHollow Technologies
  More Information

ClinicalTrials.gov Identifier: NCT00516308     History of Changes
Other Study ID Numbers: FHT-P-07-004
First Submitted: August 13, 2007
First Posted: August 15, 2007
Last Update Posted: January 18, 2008
Last Verified: January 2008

Keywords provided by FoxHollow Technologies:
CLI
Critical Limb Ischemia
PAD
Paripheral Arterial Disease
Artherosclerosis
Leg pain
Cardiovascular
Atherectomy
NightHawk

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases