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Clinical Trials/NCT05569369
NCT05569369Not yet recruitingNot Applicable

Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions in Patients With Chronic Lower Limb Threatening Ischemia

Sohag University0 sites25 target enrollmentStarted: November 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
25
Primary Endpoint
sustained clinical improvement.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to evaluate the technical feasibility, safety, and 1-year clinical efficacy of the endovascular treatment of patients with atherosclerotic common femoral artery (CFA) obstructions with associated superficial femoral artery lesions. Participants will undergo angioplasty with or without stenting of common femoral and superficial femoral arteries.

Detailed Description

Study design:

It is a prospective study which will include patients who need revascularization after approval of this study from local ethical committee and obtaining written informed consent.

Study setting:

This study will be done in Sohag University Hospitals and in Cairo University Hospitals.

Study sample:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Serum creatinine <
  • •Complaining of chronic lower limb threatening ischemia due to denovo atherosclerotic disease i.e. no previous intervention of common femoral artery with associated superficial femoral artery lesion (Rutherford stages 2-5).

Exclusion Criteria

  • •- Non-atherosclerotic conditions (for example: vasculitis, collagen vascular disease, Buerger's disease, radiation).
  • •Acute limb ischemia.

Outcomes

Primary Outcomes

sustained clinical improvement.

Time Frame: 1 year

a sustained upward shift of ≥1 category of the Rutherford classification without the need for repeated target lesion revascularization in surviving patients.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hossam Eldin AHmed Soliman

Hossam Eldin Ahmed Soliman Mohamed

Sohag University

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