Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
LineMatrix® Biological Vascular Graft for Infrarenal Arterial Bypass or Replacement
Primary patency rate at 6 months postoperatively
Defined as: the proportion of vascular graft patency without additional intervention.
Time frame: 6 Months
Primary patency rate at 3 months and 12 months postoperatively
Defined as: the proportion of vascular graft patency without additional intervention.
Time frame: 3-12 Months
Cumulative patency rate at 3 months, 6 months, and 12 months
Defined as the proportion of subjects whose artificial vascular bypass graft has not been abandoned from the date of bypass establishment up to 12 months postoperatively.
Time frame: 3-12 Months
Amputation-free survival rate at 6 months postoperatively
Defined as: the proportion of subjects without above-ankle amputation or death from any cause at 6 months postoperatively.
Time frame: 6 Months
Limb salvage rate at 6 months postoperatively
Defined as: the proportion of subjects without above-ankle amputation at 6 months postoperatively.
Time frame: 6 Months
Surgical success rate
Defined as: successful completion of surgery using the trial device, without device-related serious adverse events during the perioperative period.
Time frame: 1 Month
Performance evaluation of biological vascular graft
I. Suturability Excellent: Needle passes through vessel with light touch and no deformation after arterial suturing; Good: Needle passes through vessel with light force and shows deformation after arterial suturing but can continue to be used; Poor: Needle passes through vessel with force and shows severe deformation after arterial suturing and cannot continue to be used. II. Anastomotic Bleeding No: No visible blood leakage at anastomosis; Yes: Visible blood leakage at anastomosis.
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Time frame: 12 Months