NCT07012551

Brief Summary

To evaluate the safety, efficacy, and outcomes of endovascular strategies for protection of the contralateral CIA in patients with symptomatic unilateral CIA occlusive disease

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started Aug 2025

Status
not yet recruiting

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

Study Progress44%
Aug 2025May 2027

First Submitted

Initial submission to the registry

June 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

June 1, 2025

Last Update Submit

June 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary patency of both common iliac arteries

    2 years

Interventions

Stenting of common iliac artery by balloon mounted stent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending the Vascular Surgery Clinics in Assiut University Hospitals complaining of unilateral CIA ostial occlusive disease, Rutherford category 3, 4and 5 will be recruited to participate in the study.

You may qualify if:

  • Symptomatic patients (Rutherford category 3- 5) due to Unilateral common iliac artery occlusive disease.
  • with or without combined iliac or femoropopliteal or infrapopliteal lesions.
  • Asymptomatic Contralateral limb.
  • Patent at least one run-off vessel

You may not qualify if:

  • Distal aorta lesion
  • contralateral CIA occlusion
  • Previous endovascular or surgical procedures for the same lesion
  • Hypersensitivity to contrast material
  • Presence of aortic or iliac aneurysms
  • Patients with unsalvageable limb
  • Non atherosclerotic lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Aboyans V, Desormais I, Lacroix P, Salazar J, Criqui MH, Laskar M. The general prognosis of patients with peripheral arterial disease differs according to the disease localization. J Am Coll Cardiol. 2010 Mar 2;55(9):898-903. doi: 10.1016/j.jacc.2009.09.055.

    PMID: 20185041BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 10, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share