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

NCT04590131 | Unknown

• 1 other identifier: Sosudi3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• MALE

  24 months

• Safety of the methods in the early postoperative period

  30 days

• MACE

  24 months

• Assessment of the quality of life in patients after surgical treatment

  24 months

Study Arms (2)

Hubrid revaskularization

EXPERIMENTAL

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.

Endovascular treatment

ACTIVE COMPARATOR

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.

Interventions

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

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.

Hubrid revaskularization

recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent. PROCEDURE

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.

Endovascular treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Meshalkin Research Institute of Pathology of Circulation

Novosibirsk, Novosibirsk Area, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Interventions

Angioplasty; Stents

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Andrey A Karpenko, PHD, MD

CONTACT

+79139504100; andreikarpenko@rambler.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, open-label, pilot study

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)