JetStream Atherectomy for the Treatment of In-stent Restenosis

unplanned major amputation, all cause mortality, and Bailout Stenting consider Target Lesion Revascularization (TLR).

Time frame: 30 days

Population: All patients were analyzed.

TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)

Time frame: 6 months

Population: 5 people died at 6 months. 1 patient had TLR before death and was counted in the TLR analysis. 4 patients were not analyzed at 6 months as they were dead before a TLR occurred (censored). So these 4 patients were excluded from the analysis at 6 months.

Defined as the change in mean ankle-brachial index (ABI) at 1 Year minus mean ABI at baseline in subjects with compressible arteries and baseline ABI \< 0.9. Units on a Scale: 0 to 1.2 (worse to normal respectively)

Time frame: 1 Year

Population: 29 patients missing because of death or ABI not obtained at visit or visit did not occur

Defined as the mean ankle-brachial index (ABI) at 6 months minus mean ABI at baseline in subjects with compressible arteries and baseline ABI \< 0.9 (0 to 1.2 is the scale ranging from severe disease to normal respectively; higher is better).

Time frame: 6 months

Population: The change in ABI at 6 months is a mean of 0.2+/- 0.3.

Defined as the change in mean Walking Impairment Questionnaire (Score 0 to 56. A higher score means a better outcome) from Baseline minus at one Year. 29.2-48.8 is the confidence interval minimum and maximum values.

Time frame: 1 Year

Population: 38.7 % improvement from baseline to 1 year.

Defined as the change in mean Walking Impairment Questionnaire (WIQ) score at 6 months minus baseline. WIQ score range is 0 to 56. A higher score means a better outcome. WIQ is reported as a change between baseline and 6 months in the score (WIQ score at 6 months minus WIQ score at baseline)

Time frame: Baseline and 6 months

Population: Data not available on 12 patients that either died or test not performed

Clinically-driven TLR (CD-TLR) was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR \>3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop \>0.15 between baseline and follow-up.

Time frame: 12 months

Population: 11/32 experienced CD-TLR at 1 year

Clinically-driven TLR (CD-TLR) at 6 months was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR \>3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop \>0.15 between baseline and follow-up.

Time frame: 6 months

Population: 8/45 experienced CD TLR (by KM)

Defined as PSVR ≤ 2.5 at the treated site or \< 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)

Time frame: 1 year

Population: 41 patients either died or did not have a Duplex Ultrasound to assess for patency at 1 year

Defined as PSVR ≤ 2.5 at the treated site or \< 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)

Time frame: 6 months

Population: 20 patients either died or had no duplex US at 6 month to assess patency

Categorized by \< 50% residual stenosis following JS atherectomy alone and without additional adjunctive PTA or bail out procedures as determined by the Angiographic Core Laboratory.

Time frame: Intraprocedural

Population: 15 patients did not have interpretable angiographic films by core lab

Defined as the change in clinical status indicated by the number of participants that had one improvement of their Rutherford Becker category by at least 1 category at 6 months. The Rutherford category is done on a scale of 0 (no symptoms) to 6 (gangrene/ulceration). A change downward from one category to another is considered an improvement.

Time frame: 6 months

Population: 38/49 77.5% participants showed improvment by at least 1 category at 6 months

Defined as ≤30% residual diameter stenosis following JS + PTA without provisional or bailout procedures

Time frame: Intraprocedural

Population: 11 patients with angiogram not interpretable by core lab

Defined as the change in clinical status indicated by the change in Rutherford Becker Class at 1 Year compared to baseline by at least one category that is attributable to the treated limb (in cases of bilateral disease). Categories are 0 which is asymptomatic to 6 which is gangrene. (Rutherford Becker Category:0=Asymptomatic, 1 = Mild Claudication, 2=moderated claudication, 3= severe claudication, 4= resting pain, 5= ulcers, 6= ulcers with gangrene.

Time frame: 1 Year

Population: 17 patients either died or Rutherford Category was not assessed due to no office visit or not evaluated.

TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year ITT (bail out stent in the Lab is not considered as TLR)

Time frame: 1 year

Population: 8 patients died at 1 year before TLR occurred and so censored out.

TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. Intra-procedural bail out stenting of the index lesion is NOT considered meeting a TLR endpoint. (ITT analysis)

Time frame: 6 months

Population: 5 patients died after hospital discharge out of 60 patients