Efficacy and Safety Comparison of the Open Surgical and Endovascular Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D.

NCT04588571 | Unknown

• 1 other identifier: Sosudi2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (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. Some studies with intervowen nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was \> 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (\>200 mm). This is a prospective, randomized, open-label 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 above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure. It is planned to recruit 110 patients (55 patients in each group). Observation period 2 years. Primary endpoint:

• The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency). Secondary endpoints:
• Clinical efficacy of the method of surgical treatment after 24 months (MALE);
• Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE);
• Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire);
• Evaluation of prognostic factors for adverse outcomes after surgical treatment.

Conditions

Atherosclerosis; Ischemia Limb; Superficial Femoral Artery Occlusion; Popliteal Artery Occlusion

Keywords

interwoven nitinol stent; atherosclerosis; prolonged occlusion of SFA; endovascular treatment; femoro-popliteal bypass; TASC II, type D

Outcome Measures

Primary Outcomes (3)

• primary patency

  primary patency is 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 is defined as a secondary procedure is performed to prevent failure (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 is 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 surgical treatment in the early postoperative period

  30 days

• MACE

  24 months

• Assessment of the quality of life

  24 months

Study Arms (2)

Endovascular treatment

EXPERIMENTAL

Patients (n=55) with recanalization of the femoral-popliteal arterial segment (TASC II, type D) above the knee with a biomimetic braided nitinol stent.

Procedure: Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent

Open surgery

ACTIVE COMPARATOR

Patients (n=55) with femoropopliteal proximal bypass with a prolonged atherosclerotic lesion of the femoropopliteal arterial segment (TASC II, type D).

Procedure: Femoropopliteal proximal bypass

Interventions

Endovascular recanalization with angioplasty and stenting with the 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 aspirin (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 aspirin (100 mg per day) for a long time and clopidogrel (75 mg per day) for 3 months.

Endovascular treatment

Femoropopliteal proximal bypass PROCEDURE

Under general anesthesia, 2 standard open surgical approaches are performed: first - to the common femoral artery, superficial femoral artery, and deep femoral artery; the second - to the first portion of the popliteal 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 shunt. Next, the shunt 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. Surgical hemostasis wound drainage and layer-by-layer wound closure are performed. Drug therapy includes pre-procedure aspirin (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 aspirin (75-100 mg per day) for a long time.

Open surgery

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;
• Symptomatic lesion (Rutherford category 3 - 6);
• Atherosclerotic prolonged occlusive lesion of the femoropopliteal arterial segment above the knee, classified by TASC II as type D, confirmed by computed tomography or arteriography;
• De novo lesion;
• Patient informed consent.

You may not qualify if:

• Age \< 18 years old;
• Potentially pregnant women;
• Asymptomatic lesion;
• Acute ischemia;
• Not de novo lesion;
• Severe comorbidity with a life expectancy of fewer than 2 years;
• Contraindications to antiplatelet therapy (double antiplatelet therapy is required for at least 2 months after the intervention);
• Patient participation in another clinical trial;

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: This is a prospective, randomized, open-label study. Group 1 (n=55): Femoropopliteal proximal bypass. Group 2 (n=55): Recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

RU (1)