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

NCT03206762 | Completed Results DMC FDA Device

• 1 other identifier: MCRF-S-001-2015
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  30 Days

Study Arms (2)

Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB

EXPERIMENTAL

Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB

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)

Device: Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm

Interventions

Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm DEVICE

Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm

Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB; POBA+DCB (Ranger or IN.PACT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midwest Cardiovascular Research Foundation: lead

Study Sites (1)

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Nicolas W Shammas
• Organization: Midwest Cardiovascular Research Foundation

shammas@mchsi.com

5633242828

Study Officials

• Nicolas Shammas, MD, Research Director

  MCRF

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 255 subjects are planned for enrollment (with a block 2:1 randomization)

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: March 28, 2018
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Locations

US (1)