NCT04108806

Brief Summary

Aim of the work : 1\. Using different calcification scoring systems to investigate the association between arterial calcification and clinical outcome following endovascular therapy

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

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

September 25, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2020

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

September 25, 2019

Last Update Submit

September 26, 2019

Conditions

PAD

Outcome Measures

Primary Outcomes (2)

  • Primary patency

    which means maintaining vessel patency without restenosis or need for re-intervention.

    1 year

  • Major adverse limb events (MALE):

    by which we mean repeated endovascular therapy, surgical revision, or major amputation during follow up period.

    1year

Study Arms (1)

Endovascular therapy

EXPERIMENTAL

Outcome of endovascular therapy on PAC

Procedure: Endovascular therapy

Interventions

Endovascular therapyPROCEDURE

Ballon dialtation of the diseased artery

Endovascular therapy

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with peripheral arterial disease
  • patients with disabling limb claudication
  • patients with rest pain
  • patients with minor tissue loss
  • patients admitted to vascular surgery department for endovascular intervention of a denovo lower limb arterial lesion

You may not qualify if:

  • )Patient's age less than 50. 2)Patients with major tissue loss \[ Rutherford category 6\] 3)Patients with recurrent lesion after previous intervention. 4)Patients with double level arterial lesion. 5) Patients refusing to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Hesham Elsayed

    Assiut University

    STUDY DIRECTOR

  • Ayman Sayed

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hazem Mohamed

CONTACT

01140210730Hazemzaki57@yahoo.com

Ahmed Bakr

CONTACT

01204510848ahmedhassan.bakr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of vascular surgery

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 30, 2019

Study Start

September 27, 2019

Primary Completion

September 1, 2020

Study Completion

September 27, 2020

Last Updated

September 30, 2019

Record last verified: 2019-09