NCT05569369

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

October 4, 2022

Last Update Submit

October 4, 2022

Conditions

Lower Limb Ischemia

Outcome Measures

Primary Outcomes (1)

  • sustained clinical improvement.

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

    1 year

Study Arms (1)

angioplasty with stenting

EXPERIMENTAL
Procedure: angioplasty and stenting

Interventions

angioplasty and stentingPROCEDURE

dilatation of stenotic arteries and insertion of stent

Also known as: atherectomy
angioplasty with stenting

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Serum creatinine \< 2.
  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AngioplastyStentsAtherectomy

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative TechniquesProstheses and ImplantsEquipment and Supplies

Central Study Contacts

hossam eldeen A soliman

CONTACT

0101045804hossameldeen.mohamed@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hossam Eldin Ahmed Soliman Mohamed

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 6, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share