010-67872107
欢迎访问北京先瑞达医疗科技公司官方网站
English
EN

AcoArt I - SFA

Home> 外周血管> 临床研究
AcoArt I - SFA

AcoArt I is the first multi'center RCT of DCB in SFA indication with 200 patients enrolled and 5 year follow up period in China

AcoArt I Study Design

blob.png

Patients Baseline

 DCB (N=100)

PTA(N=100)

P value

Age   (Y)  

65.9±9.0

65.6±8.6

0.81

Male   (%)

73   (73%)

74   (74%)

0.87

Smoking   (%)

29   (29%)

33   (33%)

0.62

BMI

23.24±3.26

23.5±3.04

0.56

Diabetes (%)

54   (54%)

57   (57%)

0.67

CHD(%)

22   (22%)

27   (27%)

0.41

Hyperlipidemia (%)

27   (27%)

29   (29%)

0.75

Hypertension   (%)

62   (62%)

72   (72%)

0.13

Rutherford   class 

             2

             3

             4

             5


14   (14%)

46   (46%)

24   (24%)

16   (16%)


12   (12%)

44   (44%)

27   (27%)

17   (17%)

0.94

ABI

0.49±0.24

0.43±0.28  

0.12


Lesion Baseline

Baseline of AcoArt I is very challenging with average lesion length at 150mm and CTO lesion % greater than 50%


 DCB (N=100)

PTA(N=100)

P value

  No. of lesions treated

1

1


   Target vessel  

      SFA

         Pop

      SFA+Pop


74   (74%)

11   (11%)

15   (15%)


76   (76%)

13   (13%)

11   (11%)

0.67

   Lesion Length (mm)

147±110

152±109

0.78

    Total Occlusions

57   (57%)

52   (52%)

0.48

   RVD (mm)

3.83±0.57

3.74±0.83

0.40

   MLD (mm)

   pre procedure

0.53±0.73

0.61±0.80

0.44

   ISR

27   (27%)

23   (23%)

0.51

    Degree of stenosis

84.4±20.3

82.6±21.3

0.56



Primary Endpoint: 6 month Late Lumen Loss

Although enrolled longest lesions, DCB group showed the largest patency improvenment compared with PTA group

image.png

60 Month Free From TLR

DCB group showed the most durable efficacy angainst PTA group compared with other leading players' products 

image.png

60 Month Safety Endpoint

No signal of incresed mortality founded in DCB group in AcoArt I (SFA) study

image.png