Peripheral Vascular DiseasesPhase 2NightHawkNCT00516308
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
A Phase 2 study testing NightHawk in people with Peripheral Vascular Diseases, run by FoxHollow Technologies at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- NightHawk
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- NightHawk
- Keywords
- CLI, Critical Limb Ischemia, PAD, Paripheral Arterial Disease, Artherosclerosis, Leg pain, Cardiovascular, Atherectomy, NightHawk
- Medical subject headings
- Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NightHawkDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Other
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FoxHollow Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516308
- Sponsor's protocol ID
- FHT-P-07-004
- Acronym
- NightHawk
- Status last verified
- Jan 2008
- First submitted
- 13 Aug 2007
- Last updated
- 18 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00516308
- Acronym / sponsor ID
- NightHawk / FHT-P-07-004
- Conditions
- Peripheral Vascular Diseases
- Keywords
- CLI, Critical Limb Ischemia, PAD, Paripheral Arterial Disease, Artherosclerosis, Leg pain, Cardiovascular, Atherectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Other
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- FoxHollow TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NightHawk | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Other). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NightHawk in people with Peripheral Vascular Diseases, run by FoxHollow Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Other). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2008.