JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon
United States47 participantsStarted 2018-03-28
Plain-language 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 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Has a target lesion an exchangeable guidewire can cross via the true lumen (without using a re-entry device or a subintimal approach).
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.