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

Stopped early · Phase 2

Conditions studied: Peripheral Vascular Diseases

In brief

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.

Key facts

Study ID

NCT00516308

Run by

FoxHollow Technologies

People needed

100

Starts

2007-08-01

Expected to finish

2007-12-01

Last updated by the study team

2008-01-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Austin Heart — Austin, Texas, United States

Full record on ClinicalTrials.gov

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