Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
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.
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%;
Single group
LineMatrix® Biological Vascular Graft
DeviceLineMatrix® 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.
Primary patency rate at 3 months and 12 months postoperatively
Defined as: the proportion of vascular graft patency without additional intervention.
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.
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.
Limb salvage rate at 6 months postoperatively
Defined as: the proportion of subjects without above-ankle amputation at 6 months postoperatively.
Clinical adverse events
Cardiovascular and cerebrovascular events, death
Incidence of surgery-related complications
Including: aneurysm, vascular stenosis, thrombosis, infection, anastomotic bleeding or spontaneous rupture/pseudoaneurysm, etc.
Device defect incidence rate
Incidence rate of adverse events and serious adverse events.
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Shanghai Zhongshan Hospital
Lead sponsor
Humatrix Medical Technology (Suzhou) Co., LTD
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
