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OpenTrials
Completed

NCT Number: NCT04490408

Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia

The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse.
  • Fontaine classification stage IV (gangrene or necrosis).
  • Rutherford grade III and IV category 5 and 6 with salvageable foot

Exclusion criteria

  • heart failure
  • liver failure
  • renal impairment

Treatment and study plan

long surgical bypass

Procedure

long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.

Hybrid approach

Procedure

Hybrid approach including bypass and endovascular revascularization

Primary outcomes

  1. Late occlusion

    Time frame: 2 years

    Late occlusion of the affected vessels

Sponsors and collaborators

Lead sponsor

Egyptian Biomedical Research Network

Network

Registry information

Official study title

Long Surgical Bypass Versus Hybrid Approaches for Management of Critical Limb Ischemia

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 29, 2020
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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