NCT03824730

Brief Summary

This study compares early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

January 1, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

4.8 years

First QC Date

January 25, 2019

Last Update Submit

January 29, 2019

Conditions

Aorto-Iliac Occlusive DiseaseIliac Artery OcclusionIliac Artery Disease

Keywords

endovascularstentaorto-iliacocclusionsiliac

Outcome Measures

Primary Outcomes (1)

  • Primary artery/stent patency rate

    Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation.

    60 Months

Secondary Outcomes (4)

  • Primary assisted artery/stent patency rate

    60 months

  • Secondary patency artery/stent rate

    60 months

  • Clinical success

    60 months

  • Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment

    1 month

Study Arms (1)

Endovascular occlusions group

Group of patients with aorto-iliac occlusive disease (TASC B, C, D) in whom stenting of the Common and/or External Iliac Arteries were performed

Device: Stenting of the Common and/or External Iliac Arteries

Interventions

Stenting of the Common and/or External Iliac ArteriesDEVICE

Stenting of the Common and/or External Iliac Arteries was performed in the angiographic suite. Under local anesthesia, arterial access was obtained through standard percutaneous puncture of the common femoral artery, brachial approach, or simultaneous brachial and femoral approach. Iliac lesion crossing was achieved through intraluminal or subintimal manner depending on the behavior of the lesion intraoperatively. Predilatation of the occlusion before stent deployment was performed at the discretion of the operator. Balloon-expandable stents were used for proximal, ostial lesions, whereas self-expanding stents were deployed in all other lesions. Both stents were used in long lesions involving heavily calcified common iliac arteries.

Also known as: Percutaneous Transluminal Angioplasty, stent implantation
Endovascular occlusions group

Eligibility Criteria

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

Patients treated with endovascular stent due to aorto-iliac occlusions

You may qualify if:

  • Patient has aorto-iliac occlusions type B, C \& D according to TASC-II classification
  • Patient suffers from severe claudication (Rutherford 3) or critical limb ischemia (Rutherford 4 and 5)
  • Patients fulfilling criteria for endovascular treatment of aorto-iliac occlusion according to criteria of the participating centres.

You may not qualify if:

  • Patients with associated abdominal or iliac aneurysm, restenotic lesions, acute thrombi or dissections,
  • Patients who experienced an initial technical failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Institute for Cardiovascular Diseases Dedinje

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Bites and Stings

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Dragan Z Sagic, Prof

    Institute for Cardiovascular Diseases Dedinje

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 31, 2019

Study Start

January 1, 2013

Primary Completion

November 1, 2017

Study Completion

September 1, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)