Peripheral Arterial Disease
Conditions
Brief summary
Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
Interventions
LineMatrix® Biological Vascular Graft for Infrarenal Arterial Bypass or Replacement
Sponsors
Shanghai Zhongshan Hospital
Humatrix Medical Technology (Suzhou) Co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1.Adults aged ≥18 and ≤80 years, inclusive; * 2.Patients evaluated by the investigative staff as requiring infra-renal arterial bypass or arterial replacement, including but not limited to: ischemia, infection, trauma, arterial rupture; * 3.For ischemic limbs requiring infra-inguinal arterial bypass, Rutherford stage 3-6; Ankle-Brachial Index (ABI) ≤0.6; Preoperative imaging showing at least one below-knee artery vessel patent to the ankle with good runoff; No whole-segment healthy great saphenous vein available; * 4.Patients who are able to communicate effectively with investigative staff, competent and willing to give written informed consent, and are able to comply with entire study procedures including all scheduled follow-up visits.
Exclusion criteria
* 1.Distal target artery diameter \<2.5mm; * 2.Known or suspected allergy to contrast media, anticoagulant/antiplatelet drugs, alcohol, or bovine-derived products; * 3.Hemoglobin \<60g/L, platelet count \<60×10⁹/L; * 4.Left ventricular ejection fraction \<30%; * 5.Severe cardiac disease: including New York Heart Association (NYHA) Scale III-IV severe heart failure, or a history of myocardial infarction, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina within 3 months; * 6.Stroke within 3 months prior to study entry; * 7.Uncontrolled or poorly controlled diabetes (preoperative glycated hemoglobin \>10%); * 8.Active inflammatory vascular disease; * 9.Patients with autoimmune diseases or currently receiving immunosuppressive drug therapy; * 10.Active malignancy or other severe systemic disease with life expectancy less than 12 months; * 11.History of heparin-induced thrombocytopenia type II (HIT-II) or other contraindications to heparin use; * 12.AST or ALT \>2× the upper limit of normal; * 13.Coagulation abnormalities (APTT or PT \>1.5× upper limit of normal); * 14.Severe psychiatric disorders that interfere with study compliance; * 15.Pregnant or breastfeeding female, intending to become pregnancy, or could not use a highly effective method of birth control during the study period; * 16.Patients in another drug or medical device clinical trials has not yet been enrolled before enrollment; * 17.There are other factors that deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate at 6 months postoperatively | 6 Months | Defined as: the proportion of vascular graft patency without additional intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate at 3 months and 12 months postoperatively | 3-12 Months | Defined as: the proportion of vascular graft patency without additional intervention. |
| Cumulative patency rate at 3 months, 6 months, and 12 months | 3-12 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. |
| Amputation-free survival rate at 6 months postoperatively | 6 Months | Defined as: the proportion of subjects without above-ankle amputation or death from any cause at 6 months postoperatively. |
| Limb salvage rate at 6 months postoperatively | 6 Months | Defined as: the proportion of subjects without above-ankle amputation at 6 months postoperatively. |
| Surgical success rate | 1 Month | Defined as: successful completion of surgery using the trial device, without device-related serious adverse events during the perioperative period. |
| Performance evaluation of biological vascular graft | 12 Months | 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. |
Contacts
CONTACTWeiguo Fu
Outcome results
None listed