Peripheral Arterial DiseasesPhase 4JETNCT01436435
The Jetstream (JET) Post-market Registry
A Phase 4 study testing Jetstream Atherectomy System in people with Peripheral Arterial Diseases, run by Boston Scientific Corporation at 11 sites in United States.
Trial summary
The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Diseases
- What is being tested?
- Jetstream Atherectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2011to Feb 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is ≥ 18 years of age.
- The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
- The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm.
- Evidence of ≥ 70% stenosis or occlusion confirmed by angiography.
- Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course before the patient is considered as entered into the study.
- Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled indications and instructions for use.
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- Lesion length ≥ 4cm.
- Patient has a Rutherford category score of 1-3.
- Patient has signed approved informed consent.
- Patient is willing to comply with the follow-up evaluations at specified times.
Who cannot join
- Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
- Patient is unable to take appropriate anti-platelet therapy.
- Patient has no patent distal runoff vessels.
- Patient has critical limb ischemia (i.e., Rutherford class 4-6)
- Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
- Interventional treatment is intended for in-stent restenosis.
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- Patient has target vessel with moderate or severe angulation (e.g., >30 degrees) or tortuosity at the treatment segment.
- Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
- Patient is receiving hemodialysis or has significantly impaired renal function (creatinine is > 2.5 mg/dl) at the time of treatment.
- Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
- Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
- Patient has had surgical or endovascular procedure in the same vascular territory within 30 days prior to the index procedure.
- Patient has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
- Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System will exclude the patient.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Lawrence Garcia, MD
Boston, Massachusetts, 02135
Lee Butterfield, MD
Columbia, South Carolina, 29204
Nicolas Shammas, MD
Davenport, Iowa, 52803
Andrey Espinoza, MD
Flemington, New Jersey, 08822
Rajesh Dave, MD
Harrisburg, Pennsylvania, 17110
Sotir Polena, MD
Huntington, New York, 11734
Chris Metzger, MD
Kingsport, Tennessee, 37660
Vinay Kumar
Laurel, Mississippi, 39440
Robert Beasley, MD
Miami, Florida, 33141
Nelson Bernardo MD
Washington D.C., District of Columbia, 20010
Ali Amin, MD
West Reading, Pennsylvania, 19611
About this study
Official title: Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)
The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.
Read the detailed description
- To observe the treatment effects of the Jetstream NAVITUS System in long, occluded, diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries.
- To assess and quantify vessel patency 1 year post atherectomy treatment.
- Conditions
- Peripheral Arterial Diseases
- Being tested
- Jetstream Atherectomy System
- Keywords
- PAD, peripheral artery disease, atherectomy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jetstream Atherectomy SystemDevice
Atherectomy
| Study group | Role | What they receive |
|---|---|---|
| Jetstream Atherectomy System | Experimental | Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Receives: Device: Jetstream Atherectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary Restenosis
Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology.
Measured: 12 months
Secondary outcomes (5)
Procedural Success
Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy
Measured: Index Procedure
Ankle-Brachial Index (ABI)
Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
Measured: 30 days
Ankle-Brachial Index (ABI)
Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
Measured: 6 months
Ankle-Brachial Index (ABI)
Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
Measured: 12 months
Major Adverse Events (MAE)
Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseasesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Gray, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436435
- Sponsor's protocol ID
- D1465
- Acronym
- JET
- Status last verified
- Sep 2016
- First submitted
- 2 Sep 2011
- Last updated
- 19 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)
- ClinicalTrials.gov ID
- NCT01436435
- Acronym / sponsor ID
- JET / D1465
- Conditions
- Peripheral Arterial Diseases
- Keywords
- PAD, peripheral artery disease, atherectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Posted 26 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.
Detailed description
- To observe the treatment effects of the Jetstream NAVITUS System in long, occluded, diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries.
- To assess and quantify vessel patency 1 year post atherectomy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jetstream Atherectomy System | Experimental | Device: Jetstream Atherectomy SystemPatients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is ≥ 18 years of age.
- The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
- The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm.
- Evidence of ≥ 70% stenosis or occlusion confirmed by angiography.
- Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course before the patient is considered as entered into the study.
Key exclusion criteria (14 listed)
- Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
- Patient is unable to take appropriate anti-platelet therapy.
- Patient has no patent distal runoff vessels.
- Patient has critical limb ischemia (i.e., Rutherford class 4-6)
- Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
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 |
|---|---|---|
| Jetstream Atherectomy SystemAtherectomy | Device | Jetstream Atherectomy System |
Primary outcome
Binary Restenosis
Time frame: 12 months
Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology.
5 secondary outcomes
Procedural Success
Time frame: Index Procedure
Ankle-Brachial Index (ABI)
Time frame: 30 days
Ankle-Brachial Index (ABI)
Time frame: 6 months
Ankle-Brachial Index (ABI)
Time frame: 12 months
Major Adverse Events (MAE)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
William Gray, MD principal investigator
Columbia University
11 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 Jetstream Atherectomy System in people with Peripheral Arterial Diseases, run by Boston Scientific Corporation at 11 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 10 inclusion and 14 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Yes. Results are posted in the registry (first posted 26 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Binary Restenosis (time frame: 12 months). 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 19 Oct 2016.