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Sponsored by: |
FoxHollow Technologies |
Information provided by: | FoxHollow Technologies |
ClinicalTrials.gov Identifier: | NCT00516308 |
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 II |
MedlinePlus related topics: | Peripheral Vascular Diseases Vascular Diseases |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | FHT-P-07-004 |
First Received: | August 13, 2007 |
Last Updated: | January 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00516308 |
Health Authority: | United States: Food and Drug Administration |
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