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

FoxHollow Technologies

Status and phase: Terminated; Phase 2

Conditions: Peripheral Vascular Diseases

Treatments: Device: NightHawk

Study type: Interventional

Funder types: Industry

Identifiers

NCT00516308

FHT-P-07-004

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)