Findings

Doppler signals

Category

Description / prognosis

Sensory loss

Muscle weakness

Arterial

Venous

I. Viable

Not immediately threatened

None

None

Audible

Audible

II. Threatened
a. Marginally

Salvageable if promptly treated

Minimal (toes) or none

None

Inaudible

Audible

     b. Immediately

Salvageable with immediate revascularization

More than toes, associated with rest pain

Mild, moderate

Inaudible

Audible

III. Irreversible

Major tissue loss or permanent nerve damage inevitables

Profound, anesthetic

Profound, paralysis (rigor)

Inaudible

Inaudible

1.

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

2.

Patient is >18 years old 

3.

Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study  

4.

Patient has a projected life-expectancy of at least 6 months 

5.

Symptomatic acute or subacute stent or bypass occlusion in the femoropopliteal artery 

6.

Target vessel diameter ≥ 3 mm and ≤ 8 mm 

7.

Patient is candidate for thrombolytic or anticoagulation medication 

8.

Patient is able and willing to comply with study follow-up requirements

1.

No patent artery until the foot  

2.

Inability of crossing lesion with guidewire   

3.

Known active infection at the time of intervention 

4.

Untreated flow-limiting inflow lesions 

5.

Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrolment 

6.

Aneurysm in the target vessel 

7.

Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol  

8.

Major distal amputation (above the transmetatarsal) in the study limb or non-study limb 

9.

Septicemia or bacteremia 

10.

Any previously known coagulation disorder, including hypercoagulability 

11.

Contraindication to anticoagulation or antiplatelet therapy 

12.

Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II 

13.

Currently participating in another clinical research trial 

14.

The patient must be excluded in case any of the contraindications as listed in the IFU is present

Age (min-max; ±SD) (years)

71.24 (51.75-87.33 ± 9.39)

Gender (%)

-Male

-Female

23 (76.67%)

7 (23.33%)

Nicotine abuse

-Never

-Former

-Current

6 (20.00%)

8 (26.67%)

16 (53.33%)

Hypertension 

-Yes, medicated

-Yes, not medicated

-No

20 (66.67%)

2 (6.67%)

8 (26.67%)

Diabetes

-Yes, type I

-Yes, type II

-No

5 (16.67%)

5 (16.67%)

20 (66.67%)

Renal insufficiency

-Yes, on dialysis

-Yes, not on dialysis

-No

2 (6.67%)

2 (6.67%)

26 (86.67%)

Hypercholesterolemia

-Yes

-No

21 (70.00%)

9 (30.00%)

Obesity

-Yes

-No

9 (30.00%)

21 (70.00%)

History of coronary intervention

-Yes

-No

8 (26.67%)
22 (73.33%)

History of cerebrovascular intervention

-Yes

-No

5 (16.67%)

25 (83.33%)

Rutherford 2

1 (3.33%)

Rutherford 3

14 (46.67%)

Rutherford 4

12 (40.00%)

Rutherford 5

3 (10.00%)

Lesion side (N=30)

-Left (%)

-Right (%)

19 (63.33%)

11 (36.67%)

Lesion Type

-Stenosis

-Occlusion   

0 (0.00%)

30 (100.00%)

Lesion length (min-max; ±SD) (mm)

170.5(15.0-500; ± 146.29)

Proximal reference vessel diameter (min-max; ±SD) (mm)

5.43 (4.0-7.0; ± 0.63)

Presence of calcification (%)

6(20.00%)

Presence of dissection (%)

1(3.33%)

Presence of thrombus (%)

22 (73.33%)

Presence of ulceration (%)

1 (3.33%)