Text Size

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

This study has been terminated.
(Other)
Sponsor:
Information provided by:
FoxHollow Technologies
ClinicalTrials.gov Identifier:
NCT00516308
First received: August 13, 2007
Last updated: January 16, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Peripheral Vascular Diseases
 Device: NightHawk
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FoxHollow Technologies:

Estimated Enrollment: 100
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516308

Locations
United States, Texas
Austin Heart
Austin, Texas, United States, 78756
Sponsors and Collaborators
FoxHollow Technologies
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00516308     History of Changes
Other Study ID Numbers: FHT-P-07-004
Study First Received: August 13, 2007
Last Updated: January 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by FoxHollow Technologies:
CLI
Critical Limb Ischemia
PAD
Paripheral Arterial Disease
Artherosclerosis
 Leg pain
Cardiovascular
Atherectomy
NightHawk

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 23, 2013