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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Vascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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NightHawk

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No