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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerosis; Ischemia Limb; Superficial Femoral Artery Occlusion; Popliteal Artery Occlusion; Stent Complication
• Intervention / Treatment: 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.

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".

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk Area
    • Novosibirsk, Novosibirsk Area, Russian Federation, 630055
      • Recruiting
      • Meshalkin Research Institute of Pathology of Circulation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hubrid revaskularization; 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.	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.; Under local anesthesia, a standard endovascular approach is performed. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion. Immediately after the stenting procedure, under local anesthesia, access to the distal part of the SFA at the outlet of Hunter's canal and 1 portion of the popliteal artery is performed. The lamina vastoadductoria is dissected. The wound is sutured in layers. An aseptic bandage is applied. Drug therapy includes pre-procedure clopidogrel (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed double antiplatelet therapy (aspirin+clopidogrel (75 mg per day) within 6 months and then aspirin 75 mg for a long time.
ACTIVE_COMPARATOR: Endovascular treatment; Patients (n=50) with recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.	Procedure: recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.; Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion. Drug therapy includes pre-procedure clopidogrel (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed double antiplatelet therapy (aspirin+clopidogrel (75 mg per day) within 6 months and then aspirin 75 mg for a long time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency	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;	24 months
primary assisted patency	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;	24 months
secondary patency	secondary patency was defined as a secondary procedure performed for graft or stent occlusion in an afterward patent vessel;	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MALE	major adverce limb events	24 months
Safety of the methods in the early postoperative period	hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area	30 days
MACE	major adverce cardio-vascular events	24 months
Assessment of the quality of life in patients after surgical treatment	SF-36 questionary	24 months

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: interwoven nitinol stent; atherosclerosis; prolonged occlusion of SFA; endovascular treatment; TASC II, type D; hybrid revascularization
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Ischemia; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: Sosudi3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No