Clinical trial NCT04590131: 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
Official title: Efficacy and Safety Comparison of the Endovascular (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent) and the Hybrid (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent, Supplemented With Fasciotomy in Hunter's Canal) Surgical Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
Ischemia Limb
Superficial Femoral Artery Occlusion
Popliteal Artery Occlusion
Stent Complication
Keywords: interwoven nitinol stent
atherosclerosis
prolonged occlusion of SFA
endovascular treatment
hybrid revascularization
TASC II, type D
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2020-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, open-label, pilot study
Primary purpose: TREATMENT

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".

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary patency
timeFrame: 24 months
measure: primary assisted patency
timeFrame: 24 months
measure: secondary patency
timeFrame: 24 months
Secondary outcomes:
measure: MALE
timeFrame: 24 months
measure: Safety of the methods in the early postoperative period
timeFrame: 30 days
measure: MACE
timeFrame: 24 months
measure: Assessment of the quality of life in patients after surgical treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin Research Institute of Pathology of Circulation
state: Novosibirsk Area
Study officials:
References: