LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement

NCT07733076 | Not Yet Recruiting

• 1 other identifier: HMX-002-CTP-01
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Primary patency rate at 6 months postoperatively

  Defined as: the proportion of vascular graft patency without additional intervention.

  6 Months

Secondary Outcomes (6)

• Primary patency rate at 3 months and 12 months postoperatively

  3-12 Months

• Cumulative patency rate at 3 months, 6 months, and 12 months

  3-12 Months

• Amputation-free survival rate at 6 months postoperatively

  6 Months

• Limb salvage rate at 6 months postoperatively

  6 Months

• Surgical success rate

  1 Month

Other Outcomes (3)

• Clinical adverse events

  12 Months

• Incidence of surgery-related complications

  12 Months

• Device defect incidence rate

  12 Months

Study Arms (1)

LineMatrix® Biological Vascular Graft

EXPERIMENTAL

Device: LineMatrix® Biological Vascular Graft

Interventions

LineMatrix® Biological Vascular Graft DEVICE

LineMatrix® Biological Vascular Graft for Infrarenal Arterial Bypass or Replacement

LineMatrix® Biological Vascular Graft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 and ≤80 years, inclusive;
• 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;
• 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;
• 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.

You may not qualify if:

• Distal target artery diameter \<2.5mm;
• Known or suspected allergy to contrast media, anticoagulant/antiplatelet drugs, alcohol, or bovine-derived products;
• Hemoglobin \<60g/L, platelet count \<60×10⁹/L;
• Left ventricular ejection fraction \<30%;
• 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;
• Stroke within 3 months prior to study entry;
• Uncontrolled or poorly controlled diabetes (preoperative glycated hemoglobin \>10%);
• Active inflammatory vascular disease;
• Patients with autoimmune diseases or currently receiving immunosuppressive drug therapy;
• Active malignancy or other severe systemic disease with life expectancy less than 12 months;
• History of heparin-induced thrombocytopenia type II (HIT-II) or other contraindications to heparin use;
• AST or ALT \>2× the upper limit of normal;
• Coagulation abnormalities (APTT or PT \>1.5× upper limit of normal);
• Severe psychiatric disorders that interfere with study compliance;
• Pregnant or breastfeeding female, intending to become pregnancy, or could not use a highly effective method of birth control during the study period;

Sponsors & Collaborators

• Humatrix Medical Technology (Suzhou) Co., LTD: collaborator
• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Weiguo Fu

CONTACT

+8613801760929; fu.weiguo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share