Patients with critical limb ischemia in the absence of optimal autologous veins.
Conditions
Interventions
1) A subcutaneous pocket is created by dissecting the skin of the abdomen and peeling the dermal layer below.
The number of BTM2 implanted per subject should be at least 2 and at most 4.
2) Insertion
Sponsors
Miyamoto Shinji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients for whom written informed consent has been obtained from the individual regarding their p articipation in the clinical trial. (2)Patients aged 18 years or older at the time of inf ormed consent (3)Individuals with critical limb ischemia meeting is chemia (Ischemia)grade 2 or 3 (ABI <0.6, SPP <40 mmHg) in the Comprehensive Advanced Chronic L eg Ischemia (Chronic Limb Threatening Ischemia; CLTI) severity WIfI categorization (Ref. 15). (4)Among patients for whom lower extremity arteria l bypass is recommended, those who meet any of t he following: a.Global Vascular Guideline(GVG) GLASS(GlobalAnatomic Staging System) of (Ref. 8) the ischemic imb of stage III in the classification, which falls und er WIfI classification clinical stage 2, 3 or 4 Ischemic limb b.GLASS stage II that falls under WIfI class clinical stage 3 or 4Ischemic limb c.GLASS stage I or II that does no t achieve adequate blood flow despite endovascula r treatment (including clinical failure that does not l ead to healing of the wound and does not improve clinical condition) d.Ischemic limb after venous bypass that does not achieve adequate blood flow despite endovascular treatment (including clinical failure not leading to healing of the wound and improvement of clinical symptoms) (5)Patients who meet the length and diameter (3 m m or higher) required for bypassing surgery and wh o do not have an optimal upper or lower extremity vein (for patients with chronic kidney disease stage G5, for patients with lower extremity vein) without a bnormal findings such as varicocele, or who are ju dged to have no vein or difficult to harvest from a medical perspective based on the eligibility commit tee. (6)Patients requiring peripheral anastomosis of byp ass to the crural or pedal arteries below the knee. (7)Patients who are judged to be able to survive for at least 12 months and to be followed up for 12 we eks after bypass surgery at the time of informed co nsent.
Exclusion criteria
Exclusion criteria: (1)Patients with a general condition in which it is dif ficult to ensure the duration of implantation of the t est device required for biotube formation because of conditions requiring immediate revascularizatio n, etc. (2)Patients with general condition judged to be diffi cult to accept operative procedures due to severe undernutrition (CONUT score 8-12) (Ref. 19) or se vere complications, etc. (3)Patients who may not have two or more implant sites for the test device because of poor skin condit ion or history of exposure to subcutaneous implant s in the past. (4)Patients undergoing invasive surgical procedure s within 30 days before enrollment (excluding proc edures for foot wounds) (5)Patients with no target arteries on the peripheral side required for bypass surgery or a history of end ovascular treatment at the site of planned peripher al anastomosis (6)Occlusion of the artery proximal to the planned s ite of anastomosis on the central side of bypass su rgery Thromboendothelial removal during bypass surger y in the present study, By releasing the occlusion by artificial vascular byp ass Unavoidable patient. (7)Patients in whom blood circulation distal to the p lanned site of distal anastomosis of bypass surgery cannot be confirmed (excluding patients in whom c ollateral circulation can be confirmed) (8)Patients undergoing lower limb amputation proxi mal to the midfoot (9)Patients with a history or concomitant malignanc y (excluding those with no recurrence or no new on set for more than 5 years after treatment) (10)Patients receiving immunosuppressive drugs f or complications of autoimmune diseases or after tr ansplantation (11)Patients with a history of allergy to stainless ste el or polyolefin resin (12)Patients who are pregnant or may be pregnant (13)Patients who are or are scheduled to participat e in other clinical trials or interventional clinical studies (14)Other than the above, patients who are judged to be inappropriate for the purpose of this clinical tri al by the principal investigator or a sub-investigator due to medical conditions, etc. or safety reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability of biotubes to form by the test instrument (BTM2). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Procedural success with respect to implantation and extraction of the test device. 2)Technical success of bypass surgery involving p eripheral anastomosis using biotubes formed by th e test instrument. 3)Patency of the biotube at 4weeks after implant ation. 4)Improvement of symptoms (improvement of isch emic pain, improvement of wounds) 5)Avoidance of major amputation. 6)Rates of additional treatment during implantation of the test device and after biotube implantation 7)QOL during test device implantation and after bi otube implantation. 8)Bypass graft diameter after bypass surgery. | — |
Contacts
Public ContactNaoto Uemura
Oita University Hospital
Outcome results
None listed