Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.
Data not available yet.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.
Trinity Bettendorf Medical Center
Bettendorf, Iowa, United States
VA Medical Center
Dallas, Texas, United States
Acute Procedural Success
Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.
Time frame: intraprocedural
Patency
Patency is defined as Peak Systolic Velocity Ratio (PSVR) of \< 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.
Time frame: 6 months
Target Lesion Revascularization
Reintervention on the same index lesion at 6 months
Time frame: 6 months
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