Figure 1a XableCath (blunt-type)

Figure 1b XableCath (abrasive-type)

Figure 2a Calcified balloon-uncrossable lesion

Figure 2b XableCath 0.018’’

Figure 2c After XableCath recanalization

Figure 2d After DES-balloon angioplasty

Table 1 Baseline characteristics and lesion data

Variables

n = 22  (24 lesions)

Female

11                                 (50.0%)

Age (years)

75.3 ± 16.7                  (54–93)

Diabetes Mellitus

16                                 (72.7%)

Hyperlipidemia

17                                 (77.3%)

Hypertension

18                                 (81.8%)

Glomerular filtration rate (GFR) ml

51.0 ± 26.4                  (32–80)

Left ventricular ejection fraction (LVEF)

51.3 ± 15.6                  (40–65)

PAD (Rutherford 3/4)

14                                 (63.6%)

        (Rutherford 5/6)

8                                    (36.4%)

Lesion characteristics

 

     Femoro-popliteal

21                                 (87.5%)

        Common iliac

  1
( 4.3%)

        Below the knee

  2 
(  8.3%)

Lesion length (mm)

56 ± 38
(12-250)

calcification

20                                 (83.3%)

total occlusions

13                                 (54.2%)

balloon-access-failures

24                                 (100%)

Table 2 XableCath Procedure Data

Number of lesions

24

XableCath application-technique

 

subintimal

          1

intraluminal

        23                        

XableCath catheter

 

0.035’’

        16

0.018’’

         8                          

Blunt-type

        24

Abrasive-type

         4                          

XableCath passes

 1.8 ± 0.8                     (1– 3)

XableCath procedure time (min)

 8.2 ± 4.1                      (3–14)

Adjunctive PTA

23                                 (95.8%)

Table 3              Results

Number lesions treated

24

Primary Procedure success

23                                 (95.8%)

Secondary Procedure success

24                                 (100%)

Minimum lumen diameter (mm)

 

At baseline

0.2 ± 0.1

After XableCath

2.4± 1.0

After adjunctive POBA/Stent

4.1 ± 1.8

Antegrade vessel flow (TIMI grade)

 

At baseline

0.7 ± 0.3

After XableCath +adj. POBA

2.9 ± 0.7

Table 4              Procedure-related Complications

Number occlusions treated

24

Perforations

  0                                 (  0%)

Dissections

  4                                 (16.7%)

Major (NHLBI type C or greater)

         0                          (  0%)

       Minor (NHLBI type A or B)

         4                          (16.7%)

Acute shunt re-closure

  0                                 (  0%)

Peripheral embolization

  0                                 (  0%)

Major access complications

  0                                 (  0%)