JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon

Completed · Not applicable

Conditions studied: Peripheral Vascular Disease

In brief

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).

Key facts

Study ID: NCT03206762
Run by: Midwest Cardiovascular Research Foundation
People needed: 47
Starts: 2018-03-28
Expected to finish: 2023-05-16
Last updated by the study team: 2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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 (< 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.

Where it is running

Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.