NCT07048925

Brief Summary

This study aims to evaluate the midterm outcomes of patients with advanced aortoiliac artery narrowing (TASC C-D lesions) who were treated with covered iliac stent-grafts instead of open surgery. These patients were either too high-risk for surgery or refused it. Medical records from the past five years at a single cardiovascular surgery center in Turkey were reviewed retrospectively. The research focuses on the success rate of the procedure, complications, vessel patency, and the need for additional treatments. The results may help guide treatment decisions in similar high-risk patients who are not candidates for open vascular surgery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

July 20, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 14, 2025

Last Update Submit

July 18, 2025

Conditions

Keywords

TASC C-D LesionsIliac Stent-GraftNon-Surgical RevascularizationCovered Stents

Outcome Measures

Primary Outcomes (1)

  • Technical and Clinical Success of Covered Iliac Stent-Graft

    Based on review of patient records over the past 5 years, including procedural success and symptom relief

    Within 5 years before the study start

Secondary Outcomes (1)

  • Complications, Patency Rates, and Reintervention Needs

    Within 5 years before the study start

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with peripheral artery disease and TASC C-D iliac lesions treated with covered stents between 2018 and 2023

You may qualify if:

  • Patients with TASC C-D iliac artery lesions
  • Procedures done within last 5 years in the same clinic
  • Aged between 18-85 years
  • Not eligible for open surgery or refused it

You may not qualify if:

  • TASC A-B lesions
  • Age \<18 or \>85

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University Faculty of Medicine

Samsun, 55090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Emrah Ereren

    Samsun University Faculty of medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2025

First Posted

July 3, 2025

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

August 30, 2025

Last Updated

July 20, 2025

Record last verified: 2025-06

Locations