Efficacy and Safety Comparison of the Endovascular and the Hybrid Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D
- Conditions
- Ischemia LimbPopliteal Artery OcclusionSuperficial Femoral Artery OcclusionStent ComplicationAtherosclerosis
- Interventions
- Procedure: recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal.Procedure: recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.
- Registration Number
- NCT04590131
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Brief Summary
A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (\>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Another possible solution to the problem of stent breakage in the femoral-popliteal position is fasciotomy in Gunter's canal with dissection of the lamina vasto-adductoria. According to a pilot randomized study (Karpenko et al, 2019), the primary patency at 24 months was 60% in the stenting group supplemented with fasciotomy in Gunter's canal, and 28.5% in the stenting group without fasciotomy. These facts prove the need for a comparative study on a cohort of patients using a biomimetic interwoven nitinol stent. This is a pilot prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two methods of treating prolonged atherosclerotic lesions (TASC II, type D) of the arteries of the femoropopliteal segment above the knee.
- Detailed Description
A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (\>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Another possible solution to the problem of stent breakage in the femoral-popliteal position is fasciotomy in Gunter's canal with dissection of the lamina vasto-adductoria. According to a pilot randomized study (Karpenko et al, 2019), the primary patency at 24 months was 60% in the stenting group supplemented with fasciotomy in Gunter's canal, and 28.5% in the stenting group without fasciotomy. These facts prove the need for a comparative study on a cohort of patients using a biomimetic interwoven nitinol stent. This is a pilot prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two methods of treating prolonged atherosclerotic lesions (TASC II, type D) of the arteries of the femoropopliteal segment above the knee.
Screening It is performed in patients with a verified diagnosed occlusive lesion of the femoropopliteal segment above the knee (type D by TASC II classification), with chronic limb ischemia (3-6 categories by Rutherford classification). Assessment of inclusion / exclusion criteria, assigning a patient number.
Study inclusion Collecting baseline information about the patient (anamnesis, including information about concomitant therapy, data from the initial physical examination, ultrasound data of the lower limb arteries, CT-angiography data, assessment of the quality of life using the SF-36 questionnaire). Randomization using the envelope method to one group or another.
Surgical intervention:
Group 1 (n=50): Recanalization of prolonged occlusion of the arteries of the femoral-popliteal segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent; Group 2 (n=50): Recanalization of prolonged occlusion of the arteries of the femoropopliteal segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Gunter's canal.
Follow up: 6, 12, 24 months.
Performed:
Triplex ultrasound of one lower limb (restenosis, thrombosis, stent breakage); Radiography of the operated limb in two projections, for patients in whom a stent breakage is suspected according to ultrasound; Consultation with a cardiovascular surgeon. For each patient participating in the study, a CRF is filled out in a form convenient for the Investigator. The creation of a folder "Investigator's file" is provided, which stores all the necessary documents provided for by the rules of "Good Clinical Practice".
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- age> 18 years;
- CLI category 3 - 6 by Rutherford classification;
- Prolonged atherosclerotic occlusive lesion of the femoropopliteal arterial segment above the knee (Type D by TASC II classification), confirmed by CT or arteriography;
- De novo lesion;
- Patient informed consent.
- Age < 18;
- Potentially pregnant women;
- Asymptomatic lesion;
- Acute ischemia;
- Previous treatment on the affected segment;
- Not atherosclerotic lesion;
- Severe comorbidity with a life expectancy of fewer than 2 years;
- Contraindications to antiplatelet therapy;
- Patient participation in another clinical trial;
- Inability to monitor the patient.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hubrid revaskularization recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal. Patients (n=50) with recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal. Endovascular treatment recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent. Patients (n=50) with recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.
- Primary Outcome Measures
Name Time Method primary assisted patency 24 months primary assisted patency was defined as a secondary procedure is performed to prevent failure (i.e., in a flow-limiting stenosis \[PSV ratio \>2.5\] in a still-patent segment of stent or bypass, including the anastomoses;
secondary patency 24 months secondary patency was defined as a secondary procedure performed for graft or stent occlusion in an afterward patent vessel;
Primary patency 24 months primary patency was defined as absence of occlusion or flow-limiting stenosis (peak systolic velocity \[PSV\] ratio \>2.5) of the treated segment including 1 cm proximal and distal of the anastomosis;
- Secondary Outcome Measures
Name Time Method MALE 24 months major adverce limb events
MACE 24 months major adverce cardio-vascular events
Safety of the methods in the early postoperative period 30 days hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area
Assessment of the quality of life in patients after surgical treatment 24 months SF-36 questionary
Trial Locations
- Locations (1)
Meshalkin Research Institute of Pathology of Circulation
🇷🇺Novosibirsk, Novosibirsk Area, Russian Federation