JetStream Atherectomy for the Treatment of In-stent Restenosis

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 Food and Drug Administration (FDA) for use in the
peripheral vasculature to treat denovo and non-stent infrainguinal lesions

Several studies have shown that stenting of the FP artery leads to higher long term patency.
Bare metal stents however have not shown conclusively to reducemTLR which is in contrast to
drug coated balloons (DCB) and drug coated stents (DCS). Irrespective, stenting has several
disadvantages including a continued high rate of restenosis and stent fractures that is
progressive with time. FP ISR occurs in more than one third of patients at 1 year and up to
49% at 2 years. Complex lesions (long, Trans-Atlantic Inter-Society Consensus II C/D lesions,
total occlusions), certain demographics (female gender, diabetes mellitus), critical limb
ischemia and significant stent fractures are associated with a higher rate of restenosis.
Also the majority of occluded stents are restenotic-thrombotic and generally are more
challenging to treat.

Recently 3 randomized trials were presented in treating FP ISR; the EXCImer Laser Randomized
Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis (EXCITE ISR) trial
(randomized laser + PTA vs PTA alone), the RELINE trial (Propaten Bioactive Surface vs.
standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral
artery) and the Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial. All these studies
showed superiority over PTA in treating FP ISR. Early animal data (porcine model of FP ISR)
and feasibility human data (JetStream ISR study) have shown that the JetStream device is
effective in ablating restenotic tissue within restenotic FP stents and had no safety
concerns within well apposed stents and in the absence of Class III and IV fractures.

The purpose of this study is to assess and estimate the effect of treating FP ISR with plaque
excision using JS in combination with adjunctive PTA and compare this to historic control of
PTA. The comparator arm is historic data from PTA derived from a study-level meta-analysis of
the 3 published randomized trials in the field.

Inclusion Criteria:

1. Patients with symptomatic peripheral arterial disease (Rutherford Becker Class II to
IV)

2. Previously treated with stenting in the femoropopliteal segment

3. No limit on how many times the target in-stent restenotic lesion has been previously
treated.

4. 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

5. 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:

1. Subject is 18 years of age or older.

2. Subject presents with clinical evidence of peripheral arterial disease with ISR in the
femoropopliteal segment (includes common femoral, superficial femoral and popliteal)

3. Subject presents with a Rutherford Classification of 2-4 and has symptoms of rest limb
pain or claudication.

4. Target lesion(s) must be viewed angiographically and have ≥50% stenosis.

5. 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.

6. The main target vessel reference diameter must be > or = 5 mm and ≤ 7 mm

7. One patent distal run-off vessel with <70% disease and with brisk flow is required.

8. Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to
verify this per operator's discretion

9. Patient has signed approved informed consent.

10. Patient is willing to comply with the follow-up evaluations at specified times.