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Full Metall Jacket Multilevel Segment

NCT04461496 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-07-13

No results posted yet for this study

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

Interventions

PROCEDURE

Hybrid revascularization

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

PROCEDURE

Full metall Jacket

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.

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2025-06-05
Completion
2025-06-05

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461496 on ClinicalTrials.gov