Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia

NCT04583436 | Unknown

• 1 other identifier: Sosudi1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is prospective, randomized study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment below the knee, TASC II type D - femoropopliteal distal bypass with a synthetic ePTDE-grafts and recanalization with angioplasty and stenting using a biomimetic intervowen nitinol stent in patients with symptomatic peripheral arterial disease after 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operated segment and compare the quality of life of patients after the procedure.

Conditions

Atherosclerotic Ischemic Disease; Critical Limb Ischemia; Superficial Femoral Artery Occlusion; Popliteal Artery Occlusion

Keywords

intervowen biomimetic nitinol stent; TASC D; femoro-popliteal distal bypass; Critical limb ischemia

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 method of surgical treatment 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)

Endovascular recanalization

EXPERIMENTAL

Recanalization with angioplasty and stenting: Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Perform transluminal or subintimal recanalization of the occluded segment of the arteries with a hydrophilic guide wire. Next, balloon angoplasty of the recanalized segment is performed. After control angiography, a biomimetic braided nitinol stent is placed throughout the lesion. n=45

Device: Endovascular recanalization

Open surgery

ACTIVE COMPARATOR

Femoropopliteal distal bypass with a synthetic ePTFE graft: Under general anesthesia, 2 standard open surgical approaches are performed: one to the common femoral artery, superficial femoral artery and deep femoral artery; the second - to the third portion of the popliteal artery, the tibioperoneal trunk and the anterior tibial artery. After systemic heparinization, clamps are applied to the arteries. A longitudinal arteriotomy of the popliteal artery is performed, and a distal end-to-side anastomosis is formed between the artery and the graft. Next, the graft is passed into the groin wound. Longitudinal arteriotomy of the common femoral artery. A proximal end-to-side anastomosis is formed between the shunt and the common femoral artery. Clamps are removed from arteries, blood flow is started, surgical hemostasis, wound drainage, layer-by-layer wound closure is performed. n=45

Other: Open surgery

Interventions

Endovascular recanalization DEVICE

Recanalization with angioplasty and stenting: Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Perform transluminal or subintimal recanalization of the occluded segment of the arteries with a hydrophilic guide wire. Next, balloon angoplasty of the recanalized segment is performed. After control angiography, a biomimetic braided nitinol stent is placed throughout the lesion.

Endovascular recanalization

Open surgery OTHER

Femoropopliteal distal bypass with a synthetic ePTFE graft: Under general anesthesia, 2 standard open surgical approaches are performed: one to the common femoral artery, superficial femoral artery and deep femoral artery; the second - to the third portion of the popliteal artery, the tibioperoneal trunk and the anterior tibial artery. After systemic heparinization, clamps are applied to the arteries. A longitudinal arteriotomy of the popliteal artery is performed, and a distal end-to-side anastomosis is formed between the artery and the graft. Next, the graft is passed into the groin wound. Longitudinal arteriotomy of the common femoral artery. A proximal end-to-side anastomosis is formed between the shunt and the common femoral artery. Clamps are removed from arteries, blood flow is started, surgical hemostasis, wound drainage, layer-by-layer wound closure is performed.

Open surgery

Eligibility Criteria

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

You may qualify if:

• Adults patients (\>18 years old);
• Critical limb ischemia (4-6 Rutherford category);
• Atherosclerotic occlusive lesion of the arteries of the femoropopliteal segment below the knee joint, classified by TASC II as type D, confirmed by computed tomography or arteriography;
• De Novo lession;
• Patient consent;
• Lack of suitable autologous shunting material (GSV)

You may not qualify if:

• Juvenile patient (\< 18 years old);
• Pregnancy;
• Asymptomatic lession;
• Acute ischemia;
• Previous treatment on the target lession;
• Non-atherosclerotic lession;
• Severe comorbidity with a life expectancy - less than 2 years;
• Contraindications to antiplatelet therapy;
• Patient participation in another clinical trial;
• Patient refusal to participate in the study;
• Availability of suitable autologous bypass material.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Meshalkin National Medical Research Center Ministry of healthcare of Russia

Novosibirsk, Novosibirsk Area, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Andrey A. Karpenko, MD, prof.

CONTACT

+79139504100; andreilarpenko@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: Group 1: Femoropopliteal distal bypass with a synthetic ePTFE graft; Group 2: Recanalization of occlusion of the arteries of the femoropopliteal segment below the knee joint with angioplasty and stenting with a biomimetic intervowen nitinol stent.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 12, 2020

Record last verified: 2020-10

Locations

RU (1)