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

Sponsor

FoxHollow Technologies (Industry)

Overall Status

Terminated

CT.gov ID

NCT00516308

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

24.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Diseases	Device: NightHawk	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.