N/A
N=60
JetStream Atherectomy for the Treatment of In-stent Restenosis
Femoropopliteal In-stent Restenosis
Bottom Line
View on ClinicalTrials.gov: NCT02730234 ↗Enrolled (actual)
60
Serious AEs
35.0%
Results posted
Jan 2021
Primary outcome: Primary: Percentage of Participants With Target Lesion Revascularization (TLR) — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- JetStream XC with balloon angioplasty (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Midwest Cardiovascular Research Foundation
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Target Lesion Revascularization (TLR) |
12 | — |
| PRIMARY Major Adverse Events (MAE) |
6 | — |
| SECONDARY Device Outcome |
25 | — |
| SECONDARY Procedural Success |
35 | — |
| SECONDARY Target Lesion Revascularization (TLR) With no Bailout Stent Included |
6 | — |
| SECONDARY Target Lesion Revascularization (TLR) |
18 | — |
| SECONDARY Clinical Patency |
15 | — |
| SECONDARY Clinical Patency |
15 | — |
| SECONDARY Change in Walking Impairment Questionnaire Score |
21.8 | — |
| SECONDARY Number of Participants With Rutherford Clinical Category Improvement |
38 | — |
| SECONDARY Change in Ankle-Brachial Index |
0.2 | — |
| SECONDARY Change in Walking Impairment Questionnaire at 1 Year |
38.7 | — |
| SECONDARY Rutherford Clinical Category |
35 | — |
| SECONDARY Ankle Brachial Index |
0.2 | — |
| SECONDARY Clinically Driven Target Lesion Revascularization |
11 | — |
| SECONDARY Clinically Driven Target Lesion Revascularization |
11 | — |
Summary
The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic data from PTA alone in the treatment of femoropopliteal (FP) arterial In-stent restenotic (ISR) disease.
This is a prospective, multicenter, single arm study evaluating the investigational use of Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the field.
Eligibility Criteria
Inclusion Criteria
- Patients with symptomatic peripheral arterial disease (Rutherford Becker Class II to IV)
- Previously treated with stenting in the femoropopliteal segment
- No limit on how many times the target in-stent restenotic lesion has been previously treated.
- There is no exclusion based on how the prior treatment was done including if drug eluting balloons or stents have been used. Covered stents cannot be included
- There is no limit on the length of the target lesion as long as only one target lesion is treated and enrolled
Exclusion Criteria
Subjects must meet all of the following criteria to be eligible to participate in this study:
- Subject is 18 years of age or older.
- Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
- Subject presents with a Rutherford Classification of 2-4 and has symptoms of rest limb pain or claudication.
- Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
- The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.
- The main target vessel reference diameter must be > or = 5 mm and ≤ 7 mm
- One patent distal run-off vessel with <70% disease and with brisk flow is required.
- Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion
- Patient has signed approved informed consent.
- Patient is willing to comply with the follow-up evaluations at specified times.
Data sourced from ClinicalTrials.gov (NCT02730234). 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.