RestenosisJetStreamISRNCT01722877
JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
A study testing JetStream Navitus in people with Restenosis and Peripheral Vascular Disease, run by Midwest Cardiovascular Research Foundation at 2 sites in United States.
Trial summary
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restenosis, Peripheral Vascular Disease
- What is being tested?
- JetStream Navitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Sep 2015
- Phase
- Interventional
- 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
- Subject is 18 years of age or older.
- Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
- Subject presents with a Rutherford Classification of 1-5 and has symptoms of rest limb pain, ulcerations or claudication.
- Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
- The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.
- The main target vessel reference diameter must be at least 5 mm.
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- One patent distal run-off vessel with brisk flow is required.
- Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled instructions for use.
- Patient has signed approved informed consent.
- Patient is willing to comply with the follow-up evaluations at specified times.
Who cannot join
- Subject is unable to understand the study or has a history of non-compliance with medical advice.
- Subject is unwilling or unable to sign the Informed Consent Form (ICF).
- Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints (e.g., limit use of study-recommended medications, etc.).
- Subject is pregnant or planning to become pregnant within the study period.
- Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.
- Subject is diagnosed with chronic renal failure or has a creatinine level > 2.5 mg/dl and is not on chronic dialysis.
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- Subject has a known allergy to heparin, ASA, Plavix.
- Subject has a history of bleeding disorders or platelet count < 80,000 cells/ml.
- Subject experiences ongoing cardiac problems (e.g., cardiac arrhythmias, congestive heart failure exacerbation, myocardial infarction, etc.) that, per the investigator, would not make the subject an ideal candidate for study procedures.
- Subject has a CVA or TIA within 4 weeks prior to JetStream procedure.
- Subject has an anticipated life span of less than 6 months.
- Subject is suspected of having an active systemic infection.
- Subject per the investigator's medical judgment must be excluded from the study.
- Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
- 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 any planned surgical intervention or endovascular procedure within 15 days after the index procedure.
- Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System.
- Use of another debulking device after the Jetstream NAVITUS system.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Trinity Bettendorf Medical Center
Bettendorf, Iowa, 52722
VA Medical Center
Dallas, Texas
About this study
Official title: Safety and Effectiveness of JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions: A Prospective Registry
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.
Read the detailed description
Data not available yet.
- Conditions
- Restenosis, Peripheral Vascular Disease
- Being tested
- JetStream Navitus
- Keywords
- Restenosis, aspiration, in-stent restenosis, atherectomy, superficial femoral artery, popliteal artery
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JetStream NavitusDevice
Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.
| Study group | Role | What they receive |
|---|---|---|
| JetStream Atherectomy | Experimental | Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. Receives: Device: JetStream Navitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Procedural Success
Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.
Measured: intraprocedural
Secondary outcomes (2)
Patency
Patency is defined as Peak Systolic Velocity Ratio (PSVR) of < 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.
Measured: 6 months
Target Lesion Revascularization
Reintervention on the same index lesion at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2014
- Study completionSep 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RestenosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Cardiovascular Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- MEDRAD, Inc.
- Responsible party
- Sponsor
- Investigators
- Nicolas W Shammas, MD, MS, Principal investigator, Midwest Cardiovascular Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722877
- Sponsor's protocol ID
- JS-ISR-001, version 1, Rev 2
- Acronym
- JetStreamISR
- Status last verified
- Feb 2020
- First submitted
- 5 Nov 2012
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Manuscript will be published in JEVT early 2016
Publications
Shammas NW, Shammas GA, Banerjee S, Popma JJ, Mohammad A, Jerin M. JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: Results of the JETSTREAM-ISR Feasibility Study. J Endovasc Ther. 2016 Apr;23(2):339-46. doi: 10.1177/1526602816634028. Epub 2016 Feb 26.
PubMed 26921281
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions: A Prospective Registry
- ClinicalTrials.gov ID
- NCT01722877
- Acronym / sponsor ID
- JetStreamISR / JS-ISR-001, version 1, Rev 2
- Conditions
- Restenosis, Peripheral Vascular Disease
- Keywords
- Restenosis, aspiration, in-stent restenosis, atherectomy, superficial femoral artery, popliteal artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Midwest Cardiovascular Research FoundationUniversity, hospital or other
- Collaborators
- MEDRAD, Inc.
- Study start
- Oct 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.
Detailed description
Data not available yet.
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 | Experimental | Device: JetStream NavitusJetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is 18 years of age or older.
- Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
- Subject presents with a Rutherford Classification of 1-5 and has symptoms of rest limb pain, ulcerations or claudication.
- Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
- The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.
Key exclusion criteria (20 listed)
- Subject is unable to understand the study or has a history of non-compliance with medical advice.
- Subject is unwilling or unable to sign the Informed Consent Form (ICF).
- Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints (e.g., limit use of study-recommended medications, etc.).
- Subject is pregnant or planning to become pregnant within the study period.
- Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.
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 NavitusStudy to use Jetstream device for use of in-stent restenosis in femoral popliteal artery. | Device | JetStream Atherectomy |
Primary outcome
Acute Procedural Success
Time frame: intraprocedural
Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.
2 secondary outcomes
Patency
Time frame: 6 months
Target Lesion Revascularization
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26921281Shammas NW, Shammas GA, Banerjee S, Popma JJ, Mohammad A, Jerin M. JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: Results of the JETSTREAM-ISR Feasibility Study. J Endovasc Ther. 2016 Apr;23(2):339-46. doi: 10.1177/1526602816634028. Epub 2016 Feb 26.
- Individual participant dataSharing planned: Yes. Manuscript will be published in JEVT early 2016
Related trials for Restenosis
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
In-Stent Restenosis
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
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.
Nicolas W Shammas, MD, MS principal investigator
Midwest Cardiovascular Research Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JetStream Navitus in people with Restenosis and Peripheral Vascular Disease, run by Midwest Cardiovascular Research Foundation at 2 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 20 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2017). 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?
Acute Procedural Success (time frame: intraprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01722877, which also lists 1 linked publication.
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 3 Mar 2020.