N/A
Completed N=47
JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon
Peripheral Vascular Disease
Source: ClinicalTrials.gov NCT03206762 ↗
Enrolled (actual)
47
Serious AEs
17.0%
Results posted
May 2026
Primary outcomePrimary: Target Lesion Revascularization — 0; 8 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Lesion Revascularization |
0; 8 | — |
| PRIMARY Major Adverse Events |
0; 8; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
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:
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT03206762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.