Configuration- Main body
Proximal graft diameter |
Distal graft diameter |
Total covered length |
OD of delivery system |
20mm/22mm |
12mm |
110mm |
16Fr |
24mm |
12mm |
110mm |
18Fr |
26mm/28mm |
14mm |
110mm |
18Fr |
30mm/32mm/34mm/36mm |
14mm |
110mm |
20Fr |
Configuration- Limb
Proximal graft diameter |
Distal graft diameter |
Total covered length |
OD of delivery system |
16mm |
10mm/13mm/16mm |
60mm/80mm/95mm/110mm/125mm/140mm/155mm |
14Fr |
16mm |
16mm |
155mm |
16Fr |
16mm |
20mm |
60mm/80mm/95mm/110mm/125mm/140mm/155mm |
16Fr |
16mm |
24mm |
60mm/80mm/95mm/110mm/125mm/140mm/155mm |
18Fr |
Configuration- Iliac extension
Proximal graft diameter |
Distal graft diameter |
Total covered length |
OD of delivery system |
10mm |
10mm |
80mm |
14Fr |
13mm |
13mm |
80mm |
14Fr |
20mm |
20mm |
80mm |
16Fr |
24mm |
24mm |
80mm |
18Fr |
Configuration- PAUI
Proximal graft diameter |
Distal graft diameter |
Total covered length |
OD of delivery system |
18mm/20mm/22mm |
14mm |
110mm |
16Fr |
24mm/26mm/28mm |
14mm |
110mm |
18Fr |
30mm/32mm/34mm/36mm |
14mm |
110mm |
20Fr |
Configuration- Cuff
Proximal graft diameter |
Distal graft diameter |
Total covered length |
OD of delivery system |
20mm/22mm |
20mm/22mm |
45mm/70mm |
16Fr |
24mm/26mm/28mm |
24mm/26mm/28mm |
45mm/70mm |
18Fr |
30mm/32mm/34mm/36mm |
30mm/32mm/34mm/36mm |
45mm/70mm |
20Fr |
The clinical trial of Percutek's Abdominal Aortic Stent Graft System was an open-label, non-randomized, concurrent controlled clinical trial.
A total of 153 patients were enrolled in 11 sites, including 82 patients in the experimental group and 71 patients in the control group.
The primary effectiveness endpoint was the percentage of patients who were successfully treated for abdominal aneurysms. The success rate of was 95.8% in the experimental group and 90.6% in the control group.
Table 1 Success rate of abdominal aneurysm treatment (adjusted PPS set):
Experimental group (%, m/n) |
Control group (%, m/n) |
|
Success rate |
96.0% (72/75) |
91.0% (61/67) |
The primary safety endpoint was the percentage of patients who had no major adverse events during the perioperative period. 97.5% of patients in the experimental group had no major clinical adverse events within 30 days (perioperative period), compared with 97.0% of patients in the control group.
Table 2 Safety evaluation:
Experimental group (%, m/n) |
Control group (%, m/n) |
|
Rate of freedom from major adverse events within 30 days |
97.5% (79/81) |
97.0% (65/67) |