Peripheral Vascular DiseaseNCT03206762
JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon
A study testing Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm in people with Peripheral Vascular Disease, run by Midwest Cardiovascular Research Foundation at 1 site in United States.
Trial summary
A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with claudication (Rutherford Clinical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 16 May 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must meet all of the following general inclusion criteria.
- Has a Rutherford Clinical Category of 2 - 4.
- Is willing and capable of complying with all follow-up evaluations at the specified times (including an angiogram at the 1-year follow-up visit).
- Is ≥ 18 years old.
- Is able and willing to provide written informed consent prior to study specific procedures.
- Angiographic Inclusion Criteria:
Show all 45Show fewer
- Subject must meet all of the following angiographic inclusion criteria. Unless otherwise specified, the Investigator performing the procedure bases all angiographic inclusion criteria on visual determination at the time of the procedure.
- Has evidence at the target lesion of ≥ 70% de novo stenosis of a. ≥ 10 cm length, or b. any chronic total occlusion (> 1 month by history or known by conventional or CT angiography or arterial duplex ultrasound) in the SFA (at least 1 cm from the bifurcation of the profunda) and/or popliteal artery, or 3. at least grade 2 or higher calcification as defined by the peripheral arterial calcium scoring system (PACCS)26
- Has evidence of at least one runoff vessel to the ankle/foot of the limb to be treated that does not have significant (< 70%) stenosis during the index procedure.
- Has a reference vessel diameter of 4 - 7 mm.
- Has a target lesion an exchangeable guidewire can cross via the true lumen (without using a re-entry device or a subintimal approach).
- General Exclusion Criteria:
- The subject must not meet any of the following general exclusion criteria.
- Has one or more of the contraindications listed in the JetStream or Ranger IFUs.
- Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used (that cannot be reasonably substituted).
- Is expected to require cilostazol (Pletal) during the one-year follow-up period.
- Has a hypersensitivity to contrast material that cannot be adequately pretreated.
- Has known hypersensitivity to treatment device materials including paclitaxel or nitinol.
- Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
- Has life expectancy of less than 24 months.
- Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing.
- Has surgical or endovascular procedure of the target vessel within 30 days prior to the index procedure.
- Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
- Is currently participating in an investigational drug or another device study that may clinically interfere with the study outcomes.
- Has any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
- Has had a previous peripheral bypass affecting the target vessel (allowable for physician to pass through bypass graft in aorta-iliac region to get to the target lesion).
- Has chronic renal insufficiency (eGFR < 30 ml/min or creatinine ≥ 2.5 including dialysis patients).
- Has planned laser, cryo, TurboHawk or any other treatment except study treatment within 30 days after the index procedure.
- Has had superficial thrombophlebitis or deep venous thrombus within 30 days prior to index procedure.
- Has had a stroke within 3 months prior to index procedure.
- Has had a myocardial infarction within 1 month prior to index hospitalization
- Has history of significant gastrointestinal bleeding in the past 2 months prior to index procedure, or any history of hemorrhagic diathesis.
- Has a known or suspected systemic infection at the time of the index procedure.
- Patients with ipsilateral Iliac and CFA disease are allowed in the study but these lesions have to be treated successfully first (<30% residual) before patient can be enrolled. Treatment as per investigator's preference.
- Aneurysm located in the target vessel or aneurysmal vessel
- Angiographic Exclusion Criteria:
- The subject must not meet any of the following angiographic exclusion criteria. The Investigator performing the procedure bases all angiographic exclusion criteria on visual determination at the time of the procedure.
- Has < 70% stenosis prior to treatment of the target lesion.
- Has in-stent restenosis of the target lesion.
- Has an acute intraluminal thrombus within the target lesion.
- Has an aneurysmal target vessel
- Patient has already been enrolled in the study or any other study that by the investigator judgment may interfere with the outcome of this trial
- Has two or more lesions that require treatment in the target vessel. Lesions have to be separated by > 5 cm in order to be considered different lesions. Only one lesion per target vessel can be enrolled during the index procedure
- Has disease that precludes safe advancement of the JS device to the target lesion.
- P3 segments of the popliteal vessel.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
About this study
Official title: JETStream AtheRectomy With Adjunctive Paclitaxel-Coated BallooN Angioplasty vs Balloon AnGioplasty Followed by Paclitaxel-Coated Balloon in Treating ComplEx Denovo FemoRopopliteal Arterial Disease (JET-RANGER)
A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long (≥ 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions irrespective of length).
- Conditions
- Peripheral Vascular Disease
- Being tested
- Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
- 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 Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) ArmDevice
Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
| Study group | Role | What they receive |
|---|---|---|
| Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB | Experimental | Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB Receives: Device: Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm |
| POBA+DCB (Ranger or IN.PACT) | Active comparator | POBA and then DCB treatment (Ranger or IN.PACT) Receives: Device: Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Revascularization
Effectiveness: Target Lesion Revascularization at 1 Year: TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)
Measured: 1 year
Major Adverse Events
Safety: Major Adverse Events (MAE) at 30 days: unplanned amputation, total mortality or TLR at 30 days (TLR includes bail out stenting)
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 posted2 Jul 2017
- Study start28 Mar 2018
- Primary completion16 May 2023
- Study completion16 May 2023
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 Vascular 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 255 subjects are planned for enrollment (with a block 2:1 randomization)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Cardiovascular Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Shammas, MD, Research Director, Study director, MCRF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206762
- Sponsor's protocol ID
- MCRF-S-001-2015
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2017
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JETStream AtheRectomy With Adjunctive Paclitaxel-Coated BallooN Angioplasty vs Balloon AnGioplasty Followed by Paclitaxel-Coated Balloon in Treating ComplEx Denovo FemoRopopliteal Arterial Disease (JET-RANGER)
- ClinicalTrials.gov ID
- NCT03206762
- Acronym / sponsor ID
- MCRF-S-001-2015
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Midwest Cardiovascular Research FoundationUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long (≥ 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions irrespective of length).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 255 subjects are planned for enrollment (with a block 2:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB | Experimental | Device: Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) ArmJetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB |
| POBA+DCB (Ranger or IN.PACT) | Active comparator | Device: Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) ArmPOBA and then DCB treatment (Ranger or IN.PACT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Subject must meet all of the following general inclusion criteria.
- Has a Rutherford Clinical Category of 2 - 4.
- Is willing and capable of complying with all follow-up evaluations at the specified times (including an angiogram at the 1-year follow-up visit).
- Is ≥ 18 years old.
- Is able and willing to provide written informed consent prior to study specific procedures.
Key exclusion criteria (0 listed)
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 with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) ArmJetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm | Device | Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB, POBA+DCB (Ranger or IN.PACT) |
Primary outcome
Target Lesion Revascularization
Time frame: 1 year
Effectiveness: Target Lesion Revascularization at 1 Year: TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)
Major Adverse Events
Time frame: 30 Days
Safety: Major Adverse Events (MAE) at 30 days: unplanned amputation, total mortality or TLR at 30 days (TLR includes bail out stenting)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nicolas Shammas, MD, Research Director study director
MCRF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm in people with Peripheral Vascular Disease, run by Midwest Cardiovascular Research Foundation 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 45 inclusion and 0 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 1 May 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). 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?
Target Lesion Revascularization (time frame: 1 year). The study lists 2 primary outcomes in all. 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 1 May 2026.