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

Peripheral Vascular Diseases Clinical Trial

— NightHawk  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00516308
• Other study ID #: FHT-P-07-004
• Status: Terminated
• Phase: Phase 2
• First received: August 13, 2007
• Last updated: January 16, 2008
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: FoxHollow Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• NightHawk

Locations

Country	Name	City	State
United States	Austin Heart	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
FoxHollow Technologies

Country where clinical trial is conducted

United States,