The purpose of this randomized, multicenter study is to test the hypothesis that JetStream atherectomy (JS) with adjunctive low pressure paclitaxel coated balloon (DCB) angioplasty is superior to balloon angioplasty (PTA) and adjunctive DCB in reducing the primary outcome of target lesion revascularization (TLR) at 1- year follow-up.
Devices Used in Trial:
- JetStream XC atherectomy Device: The Boston Scientific Jetstream XC catheter is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. The JS XC System has been cleared by the FDA for use in the peripheral vasculature to treat denovo and non-stent infrainguinal lesions
- Ranger Paclitaxel-Coated Balloon Angioplasty Catheter: The Ranger PCB catheters are designed for dilating stenotic lesions and applying and delivering a drug to the vessel wall. The catheter’s dilating element is the balloon near the distal tip.
- IN.PACT Admiral Paclitaxel-Coated Balloon Angioplasty Catheter: IN.PACT Admiral is coated with a matrix of paclitaxel and an excipient urea. The coating comes into contact with water in the bloodstream upon inflation, hydrating the urea, which facilitates the release of paclitaxel at the target lesion.
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.
- Has evidence at the target lesion of ≥ 70% de novo stenosis of a. ≥ 10 cm length, or b. any chronictotal 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).
Principal Investigator: Bhaskar Purushottam, M.D., FACC.
Dr. Purushottam has been involved with cardiovascular clinical research since 2015. He completed his interventional cardiology fellowship with William Beaumont Hospital in Royal Oak, MI and his endovascular and structural interventional fellowship with Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, NY.
For more information, call Monument Health Clinical Research at 605-755-4326, email research@monument.health or visit https://clinicaltrials.gov/ct2/show/NCT03206762?term=JET-RANGER&rank=1.