Endovascular Modalites for Contralateral Common Iliac Art... | NCT07012551

Studies
Endovascular Modalites for Contralateral Common Iliac Artery in Patients With Symptomatic Unilateral Common Iliac Artery Occlusive Disease

NCT07012551

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Jun 10, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Iliac Artery Disease

Interventions

Common iliac artery stenting

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Estimated

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

May 1, 2027Estimated

First Submitted Date

Jun 1, 2025

First Submission Date that Met QC Criteria

Jun 1, 2025

First Posted Date

Jun 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2025

Last Update Posted Date

Jun 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Common iliac artery stenting	Procedure	Stenting of common iliac artery by balloon mounted stent

Measure	Description	Time Frame
Primary patency of both common iliac arteries		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
abdelrahman eltokhey	Contact	01003830585		abdelrahmaneltokhey11@gmail.com
mahmoud ismail	Contact	0106228283		mahmoudismail79@yahoo.com

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20185041	Background	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.