NCT00516308

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 18, 2008

Status Verified

January 1, 2008

Enrollment Period

4 months

First QC Date

August 13, 2007

Last Update Submit

January 16, 2008

Conditions

Peripheral Vascular Diseases

Keywords

CLICritical Limb IschemiaPADParipheral Arterial DiseaseArtherosclerosisLeg painCardiovascularAtherectomyNightHawk

Interventions

NightHawkDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Heart

Austin, Texas, 78756, United States

Location

MeSH Terms

Conditions

Peripheral Vascular DiseasesChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 15, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 18, 2008

Record last verified: 2008-01

Locations

US(1)