Full Metall Jacket Multilevel Segment

NCT04461496 | Unknown DMC

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

Brief Summary

Hypothesis: "Total" endovascular revascularization of a multistory lesion of the iliac-femoral-popliteal segment is safer and a better quality of life is achieved in comparison with hybrid intervention. The lack of damage to the skin avoids complications in the postoperative and remote periods of observation, thereby improving the quality of life

Conditions

Superficial Femoral Artery Stenosis; Iliac Artery Occlusion

Keywords

hybrid revascularization; atherosclerosis

Outcome Measures

Primary Outcomes (3)

• Efficacy of the procedure

  freedom from thrombosis was defined as the absence of occlusion by duplex ultrasonography or CT angiography of the treated segment

  24 months

• Safety of the procedure

  bleeding according to blood loss volume (millilitres) 1. intraoperative blood loss volume; 2.Postoperative blood loss volume by duplex ultrasonography and drainage losses

  30 days

• Safety of the procedure

  major adverse limb events according to clinical evaluation

  24 months

Secondary Outcomes (5)

• Primary patency

  24 months

• Secondary patency

  24 months

• Changes in the patients quality of life: questionnaire

  24 months

• Success of the procedure

  1 month

• Changes in chronic lower limb ischemia at 24 months follow-up

  24 months

Study Arms (2)

Hybrid revascularization

ACTIVE COMPARATOR

50 hybrid procedure

Procedure: Hybrid revascularization

Full metall jacket

EXPERIMENTAL

50 total endovascular interventions

Procedure: Full metall Jacket

Interventions

Hybrid revascularization PROCEDURE

The first stage is performed femoral-popliteal bypass surgery above the fissure of the knee joint according to conventional technology. Conduit is at the discretion of the operating surgeon. Intraoperatively bolus is administered sol. heparin 5000 IU. The second step is the puncture of the selected CFA with a retrograde installation of the introducer sheath. The iliac segment is recanalized with angioplasty and stent implantation in the affected area

Hybrid revascularization

Full metall Jacket PROCEDURE

The first step is the puncture contralateral CFA with a retrograde installation of the introducer. Intraoperatively bolus is administered sol. heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor. A stent is implanted in the iliac artery lesion. The second stage is the recanalization of the femoral-popliteal segment with angioplasty and stent implantation in the affected area.

Full metall jacket

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with multisegment lesions of the iliac-femoral-popliteal segment, with the distal border of the lesion above the slit of the knee joint.
• chronic ischemia 3-6 (according to Rutherford),
• the satisfactory direction of the outflow.
• Patients who gave consent to participate in this study

You may not qualify if:

• Chronic occlusion of the SFA at least 2cm
• Heavy calcification of SFA • Infection in the area of the access artery
• Expressed, more than 50% stenotic lesions of the infrarenal aorta
• Prolonged loss (TASC D) iliac artery on the side of revascularization
• aneurysmal widening of the infrarenal aorta and iliac arteries
• Hemodynamically significant lesions DFA
• Chronic heart failure III-IV functional class NYHA classification;
• decompensated Chronic "pulmonary" heart; • Severe hepatic or renal insufficiency (bilirubin \>35 mmol/l, glomerular filtration rate \<60 ml/min);
• Polyvalent drug Allergy;
• Malignant cancer in the terminal stage with a projected life span of 6 months;
• Acute stroke;
• a Pronounced calcification of the arteries of the lower limbs;
• Patients with significant lesions of the common femoral artery
• the Refusal of a patient to participate or continue to participate in the study.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Meshalkin Research Institute of Pathology of Circulation

Novosibirsk, Novosibirskaya Obl, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Andrey A Karpenko, PHD

CONTACT

89139504100; a_karpenko@meshalkin.ru

Study Design

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

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 8, 2020
• Study Start: June 30, 2020
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: July 13, 2020

Record last verified: 2020-06

Locations

RU (1)