CREDENCE BRS-1 study Study Highlights

Principal Investigator: Dr. Vimal Someshwar

Credence BRS-1 is a prospective, open-label and multicentre clinical study to evaluate the safety and performance of Credence BRS Sirolimus-Eluting BioResorbable Peripheral Scaffold System in subjects with de novo native peripheral artery lesions

The present study demonstrated favourable safety

and performance of Credence BRS Sirolimus-Eluting BioResorbable Peripheral Scaffold in de novo native peripheral artery lesion

Clinical Outcomes at

12 months

No Scaffold-related death

0% Scaffold

Thrombosis

100% Limb Salvage

0% TLR

0% Major

Amputation

Study Design A prospective, multicentre, single-arm, open-label study

Till date a total of 26 patients are enrolled

8 investigational sites across India

Clinically follow up at 30 days, 6 months, 1 year Telephonic follow up at 2 years, 3 years, 4 years and 5 years

Angiographic follow-up at 6 monthsAnalysed by Independent Core Lab-Stanford University, Stanford, CA, USA

0%Scaffold-related

mortality

0%Scaffold

Thrombosis

0%Major adverse

events

Study Results

Figure 1: Cumulative clinical events till 12 months follow-up

Figure 2: Baseline lesion characteristics of study population

0

10

20

30

40

50

Left external iliac artery

Right external iliac artery

Other

21.43

35.7142.86

Perc

enta

ge (%

)

46.43%

35.71%

10.71% 3.57%A

B1

B2

C

Figure 3: ACC/AHA Lesion type, (%)

Figure 4: Distribution of Rutherford Classification at pre-procedure and 1-month follow-up

0

29.17

3.85

33.33

23.07

16.67

50

8.3311.544.17

11.54 8.33

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pre-procedure n = 26 1 month n = 24

Rutherford Classification

Class 0 Class 1 Class 2 Class 3 Class 4 Class 5

p< 0.05

Figure 5: Rate of hemodynamic improvement as assessed by changes in Ankle-Brachial Index

0.66

0.68

0.7

0.72

0.74

0.76

0.78

0.8

0.82

Ankle Brachial Index

Pre-procedure n = 26 1 month n = 24

0.81 ± 0.25

0.71 ± 0.25

p<0.01

Figure 6: Outcome of Six-minute hall walk test at pre procedure and 1-month follow-up

0

50

100

150

200

250

300

350

Six-minute Hall Walk Test

Pre-procedure n = 26 1 month n = 24

p<0.01

185.58 ± 107.78

293.98 ± 179.94

Figure 7: Distribution of Thrombus load in patients treated with Credence BRS

14.29%

85.71%

Thrombus Load, (%)

Mild

Moderate

None

Figure 8: Calcification in patients treated with Credence BRS

Reference

1. CTRI Number: CTRI/2017/01/007638

http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15326&EncHid=&userName=CTRI/2017/01/007638

2. Gireesh Warawdekar, Initial experience with sirolimus-eluting bioresorbable peripheral scaffold for the treatment of de novo native peripheral artery lesions, The Charing Cross Symposium 2020 (21-24 April)

28.57%

21.43%

3.57%

46.43%

Calcification, (%)

Mild

Moderate

Severe

None