Peripheral Arterial DiseasePhase 4NCT00911417
A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System
A Phase 4 study testing Pathway Jetstream Atherectomy System in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by Pathway Medical Technologies Inc. at 5 sites in United States.
Trial summary
The Jetstream System is a commercially available rotating, aspirating, expandable catheter designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of this study is to use intravascular ultrasound (IVUS) during the interventional procedure to measure the amount of plaque and blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Vascular Disease
- What is being tested?
- Pathway Jetstream Atherectomy System
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2009to Aug 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is ≥ 18 years of age.
- The documented peripheral vascular disease is/are located in a superficial femoral, popliteal or tibial peroneal trunk arteries in the lower limb.
- The patient is an acceptable candidate for percutaneous intervention using the Jetstream G2 System in accordance with its labeled indications and instructions for use.
- The patient has been informed about the nature of the study and has provided informed consent.
Who cannot join
- Patient has no distal runoff.
- Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- Patient is pregnant or nursing a child.
- Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G2 System.
- Patient has clinically significant abnormal ECG or blood test results or any other factor that would put the patient at increased risk if participating in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
St. John Hospital & Medical Ctr.
Detroit, Michigan, 48236
Mount Sinai Medical Center
New York, New York, 10029
Arizona Heart Institute
Phoenix, Arizona, 85006
St. Luke's Hospital
Phoenix, Arizona, 85006
St. John's Hospital
Springfield, Illinois, 62701
About this study
Official title: The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study
The Jetstream System is a commercially available rotating, aspirating, expandable catheter designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of this study is to use intravascular ultrasound (IVUS) during the interventional procedure to measure the amount of plaque and blood clots removed by the Jetstream System.
- Being tested
- Pathway Jetstream Atherectomy System
- Keywords
- peripheral arterial disease, peripheral vascular disease
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathway Jetstream Atherectomy SystemDevice
The Pathway Jetstream System is a commercially available rotating, aspirating, expandable catheter for active removal of plaque and blood clots in peripheral arteries of the lower limbs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Morphology
Measured: up to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pathway Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Davis, MD, Principal investigator, St. John's Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911417
- Sponsor's protocol ID
- PTC09030
- Status last verified
- Sep 2011
- First submitted
- 19 May 2009
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study
- ClinicalTrials.gov ID
- NCT00911417
- Acronym / sponsor ID
- PTC09030
- Keywords
- peripheral arterial disease, peripheral vascular disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pathway Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Jun 2009 (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.
The Jetstream System is a commercially available rotating, aspirating, expandable catheter designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of this study is to use intravascular ultrasound (IVUS) during the interventional procedure to measure the amount of plaque and blood clots removed by the Jetstream System.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is ≥ 18 years of age.
- The documented peripheral vascular disease is/are located in a superficial femoral, popliteal or tibial peroneal trunk arteries in the lower limb.
- The patient is an acceptable candidate for percutaneous intervention using the Jetstream G2 System in accordance with its labeled indications and instructions for use.
- The patient has been informed about the nature of the study and has provided informed consent.
Key exclusion criteria (5 listed)
- Patient has no distal runoff.
- Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- Patient is pregnant or nursing a child.
- Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G2 System.
- Patient has clinically significant abnormal ECG or blood test results or any other factor that would put the patient at increased risk if participating in the study.
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 |
|---|---|---|
| Pathway Jetstream Atherectomy SystemThe Pathway Jetstream System is a commercially available rotating, aspirating, expandable catheter for active removal of plaque and blood clots in peripheral arteries of the lower limbs. | Device | – |
Primary outcome
Plaque Morphology
Time frame: up to 12 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2011.
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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.
Tom Davis, MD principal investigator
St. John's Hospital and Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pathway Jetstream Atherectomy System in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by Pathway Medical Technologies Inc. at 5 sites 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 4 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: finished, as of the sponsor's last update on 5 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Plaque Morphology (time frame: up to 12 month follow-up). It is what the study was designed to measure, not a finding.
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 5 Sep 2011.