Back to resultsA Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease (NightHawk)
Primary Purpose
Peripheral Vascular Diseases
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NightHawk
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring CLI, Critical Limb Ischemia, PAD, Paripheral Arterial Disease, Artherosclerosis, Leg pain, Cardiovascular, Atherectomy, NightHawk
Eligibility Criteria
Inclusion Criteria:
- Patient requires treatment for peripheral arterial disease (PAD).
- Patient is willing and able to provide Informed Consent.
- Patient has at least one focal, de novo infrainguinal lesion in a native vessel.
- The minimum reference vessel diameter is 2.0 - 4.5 mm, dependent on the NightHawk device used.
- The lesion is ≥ 50% stenosed by quantitative vascular angiography.
- The lesion is ≤ 7 cm in length.
- The patient must be able to take at least one form of anti-platelet or anti-thrombotic therapy.
Exclusion Criteria:
- Patient presents with degree of limb disease or a co-existing medical condition that makes revascularization inappropriate.
- The patient has diffuse peripheral arterial disease and/or the disease is heavily calcified.
- Patient presents with concomitant disease contraindicating an endovascular intervention.
- Patient is pregnant.
- The patient has a hypersensitivity to contrast materials that cannot be adequately pretreated.
Sites / Locations
- Austin Heart
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00516308
First Posted
August 13, 2007
Last Updated
January 16, 2008
Sponsor
FoxHollow Technologies
1. Study Identification
Unique Protocol Identification Number
NCT00516308
Brief Title
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
Acronym
NightHawk
Official Title
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Terminated
Why Stopped
Other
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
FoxHollow Technologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases
Keywords
CLI, Critical Limb Ischemia, PAD, Paripheral Arterial Disease, Artherosclerosis, Leg pain, Cardiovascular, Atherectomy, NightHawk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
NightHawk
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient requires treatment for peripheral arterial disease (PAD).
Patient is willing and able to provide Informed Consent.
Patient has at least one focal, de novo infrainguinal lesion in a native vessel.
The minimum reference vessel diameter is 2.0 - 4.5 mm, dependent on the NightHawk device used.
The lesion is ≥ 50% stenosed by quantitative vascular angiography.
The lesion is ≤ 7 cm in length.
The patient must be able to take at least one form of anti-platelet or anti-thrombotic therapy.
Exclusion Criteria:
Patient presents with degree of limb disease or a co-existing medical condition that makes revascularization inappropriate.
The patient has diffuse peripheral arterial disease and/or the disease is heavily calcified.
Patient presents with concomitant disease contraindicating an endovascular intervention.
Patient is pregnant.
The patient has a hypersensitivity to contrast materials that cannot be adequately pretreated.
Facility Information:
Facility Name
Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
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