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AcoArt II - BTK

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AcoArt II - BTK

To evaluatre the safety and efficacy of the Litos&Tulip ® drug-coated balloon (DCB) for treating below the knee (BTK) arterial disease 

Study design

Objective

To   evaluate the  safety and efficacy of   the Litos   & Tulip ® drug-coated balloon (DCB) for treatment below the knee(BTK)   arterial disease

Primary Endpoint

6-mon   Angiographic:

Primary patency (PP) – freedom from target lesion occlusionclinically-driven   target revascularization (CD-TLR) and major index limb amputation.  

Key Secondary  Endpoint

Angiographic:

Late lumen loss (LLL) at 6 months  

Clinical:

CD-TLR at 6 months   ABI at 6 months  

Complications

MAE   (death, major amputation, CD-TLR)-6mon

Subjects

11 sites, 120 pts , randomized   1:1   DCB vs. PTA


Patients baseline

DCB (N=61)

PTA (N=59)

P Value

Age, yrs

70.7±7.4

70.8±9.0

0.95

Male (%)

59%(36)

61%(36)

0.82

History of Risk Factors

CHD

Hypertension

Hyperlipidemia

Diabetes

Current smoker

Current    alcoholic


36%(22)

82%(50)

41%(25)

74%(45)

26%(16)

16%(10)


34%(20)

75%(44)

27%(16)

71%(42)

27%(16)

10%(6)


0.81

0.33

0.11

0.75

0.60

0.32

Rutherford

3

4

5

6


2%(1)

44%(27)

39%(24)

15%(9)


0

41%(24)

47%(28)

12%(7)

0.76

ABI*

0.56±0.27

0.51±0.31

0.41


Lesion baseline

DCB

PTA

P

  Patients(No)

61

59


  Lesions (No)

65

66


Target vessels

TA

TA+PTA

TA+PA

ATA

PTA

PA


1.5%(1)

9.2%(6)

4.6%(3)

49%(32)

26%(17)

9.2%(6)


1.5%(1)

6.1%(4)

7.6%(5)

50%(33)

18%(12)

17%(11)

0.59

Target lesion length (mm)

177±86

186±82

0.56

Minimal lumen diameter (mm)

0.20±0.41

0.15±0.33

0.43

Reference vessel diameter (mm)

2.55±0.34

2.53±0.35

0.71

Diameter   stenosis(%)

92%

94%

0.43

CTO (%)

75.4%(49/65)

78.8%(52/66)

0.54


Primary endpoint

DCB

N=48

PTA

N=46

P

Primary Patency

Occlusion

TLR

Amputation


78.7%   (37/48)

8

3

1


28.3%   (13/46)

27

12

1


<0.001






Secondary endpoint

DCB

PTA

P-value

Angiographic:

MLD

post procedure

6-mon

LLL  



1.66±0.41  

1.33±0.78

0.35±0.74



1.56±0.35

0.49±0.59

1.08±0.62



0.13

<0.001

<0.001


Clinical:

CD-TLR

6-mon ABI



4.9%   (3/61)

0.86±0.17


20.3%   (12/59)

0.77±0.20


0.006

0.04


Safety endpoint

DCB

PTA

P value

Death

0

0

/

Major   amputation

1.6%   (1/61)

1.7%   (1/59)

0.98

CD-TLR

4.9%   (3/61)

20.3%   (12/59)

0.01