Trial Outcomes & Findings for JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon (NCT NCT03206762)
NCT ID: NCT03206762
Last Updated: 2026-05-01
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
1 year
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB
Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB
Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm: 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)
POBA and then DCB treatment (Ranger or IN.PACT)
Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm: Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
16
|
|
Overall Study
COMPLETED
|
27
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB
Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB
Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm: 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)
POBA and then DCB treatment (Ranger or IN.PACT)
Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm: Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
Baseline Characteristics
JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon
Baseline characteristics by cohort
| Measure |
Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB
n=31 Participants
Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB
|
POBA+DCB (Ranger or IN.PACT)
n=16 Participants
Balloon angioplasty followed by adjunctive DCB treatment (Ranger or IN.PACT)
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 7.2 • n=14 Participants
|
71.5 years
STANDARD_DEVIATION 7.0 • n=34 Participants
|
70.8 years
STANDARD_DEVIATION 7.1 • n=69 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=14 Participants
|
5 Participants
n=34 Participants
|
16 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=14 Participants
|
11 Participants
n=34 Participants
|
31 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
00 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=14 Participants
|
14 Participants
n=34 Participants
|
41 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=14 Participants
|
16 participants
n=34 Participants
|
47 participants
n=69 Participants
|
PRIMARY outcome
Timeframe: 1 yearEffectiveness: 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)
Outcome measures
| Measure |
Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB
n=27 Participants
Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB
|
POBA+DCB (Ranger or IN.PACT)
n=16 Participants
POBA and then DCB treatment (Ranger or IN.PACT)
|
|---|---|---|
|
Target Lesion Revascularization
|
0 participants
|
8 participants
|
PRIMARY outcome
Timeframe: 30 DaysSafety: Major Adverse Events (MAE) at 30 days: unplanned amputation, total mortality or TLR at 30 days (TLR includes bail out stenting)
Outcome measures
| Measure |
Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB
n=31 Participants
Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB
|
POBA+DCB (Ranger or IN.PACT)
n=16 Participants
POBA and then DCB treatment (Ranger or IN.PACT)
|
|---|---|---|
|
Major Adverse Events
Target Lesion Revascularization
|
0 participants
|
8 participants
|
|
Major Adverse Events
Mortality
|
0 participants
|
0 participants
|
|
Major Adverse Events
Unplanned Amputation
|
0 participants
|
0 participants
|
Adverse Events
Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
POBA+DCB (Ranger or IN.PACT)
Serious events: 8 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB
n=31 participants at risk
Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB
|
POBA+DCB (Ranger or IN.PACT)
n=16 participants at risk
POBA and then DCB treatment (Ranger or IN.PACT)
|
|---|---|---|
|
Vascular disorders
Target Lesion Revascularization
|
0.00%
0/31 • 30 days
|
50.0%
8/16 • 30 days
|
Other adverse events
| Measure |
Jetstream Atherectomy+Ranger DCB or Medtronic IN.PACT DCB
n=31 participants at risk
Jetstream Atherectomy used in conjunction with the Ranger DCB or Medtronic IN.PACT DCB
|
POBA+DCB (Ranger or IN.PACT)
n=16 participants at risk
POBA and then DCB treatment (Ranger or IN.PACT)
|
|---|---|---|
|
Vascular disorders
Type D Dissection
|
6.5%
2/31 • Number of events 31 • 30 days
|
6.2%
1/16 • Number of events 16 • 30 days
|
Additional Information
Dr. Nicolas W Shammas
Midwest Cardiovascular Research Foundation
Phone: 5633242828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place