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Not yet recruiting NCT07733076

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

No phase Interventional Peripheral Arterial Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LineMatrix® Biological Vascular Graft.
Who it may be relevant to
Registry conditions: Peripheral Arterial Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Preliminary Study to Evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement

Overview

Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement

Interventions

  • Device LineMatrix® Biological Vascular Graft
    LineMatrix® Biological Vascular Graft for Infrarenal Arterial Bypass or Replacement

Primary outcome measures

  • Primary patency rate at 6 months postoperatively [Time frame: 6 Months]
Secondary outcome measures (6)
  • Primary patency rate at 3 months and 12 months postoperatively [Time frame: 3-12 Months]
  • Cumulative patency rate at 3 months, 6 months, and 12 months [Time frame: 3-12 Months]
  • Amputation-free survival rate at 6 months postoperatively [Time frame: 6 Months]
  • Limb salvage rate at 6 months postoperatively [Time frame: 6 Months]
  • Surgical success rate [Time frame: 1 Month]
  • Performance evaluation of biological vascular graft [Time frame: 12 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07733076 · HMX-002-CTP-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗