Determining the effectiveness of venoplasty and stent placement in improving the symptoms of chronic thrombosis in the ilio-femoral venous segment.
Design
clinical trial with single group wuth 30 cases
Settings and conduct
Vascular Surgery Center of Golestan Hospital, Ahvaz
Participants/Inclusion and exclusion criteria
inclusion criteria include patients with symptoms of chronic venous insufficiency and previous proximal deep vein thrombosis. exclusion criteria include definitive diabetic patients and patients with severe CHF or respiratory failure.
Intervention groups
Referred patients with symptoms of chronic venous insufficiency in the lower extremities
Main outcome variables
primary patency of ipsilateral illio femoral vein segment o
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201217049747N1
Registration date:2021-07-06, 1400/04/15
Registration timing:retrospective
Last update:2021-07-06, 1400/04/15
Update count:0
Registration date
2021-07-06, 1400/04/15
Registrant information
Name
Saman Ketabchian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 5799
Email address
ketabchian.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2021-06-22, 1400/04/01
Trial completion date
2021-06-22, 1400/04/01
Scientific title
Outcomes of Venoplasty with stenting in patients with chronic venous insufficiency due to DVT in iliofemoral vein segment
Public title
Outcomes of Venoplasty with stenting in patients with chronic venous insufficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
have symptoms of chronic venous insufficiency of lower extremities
evidences of previous Illiofemoral segment DVT
Exclusion criteria:
documented diabetic patients
significant heart or pulmonary disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapoor University of medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology،Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.110
Health conditions studied
1
Description of health condition studied
chronic venous insufficiency of lower extremities due to deep vein thrombosis
ICD-10 code
I87.2
ICD-10 code description
Venous insufficiency (chronic) (peripheral)
Primary outcomes
1
Description
patency of illio-femoral vein
Timepoint
primary patency of illio-femoral vein after 3 and 6 months after procedure
Method of measurement
Physical exam and dupler ultrasound
Secondary outcomes
1
Description
rate of edema
Timepoint
before procedure and at third and sixth month after procedure
Method of measurement
Measure the circumference of the middle part of the involved leg
2
Description
Involved leg ulcer condition
Timepoint
before procedure and at third and sixth month after procedure
Method of measurement
Observer assessment of wound condition based on Rutherford classification
3
Description
pain severity score
Timepoint
before procedure and at third and sixth month after procedure
Method of measurement
Score of pain intensity reported by the patient based on NRS criteria
Intervention groups
1
Description
Intervention group: venography and venoplasty and stenting in illio-femoral vein
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Vascular Surgery Center of Golestan Hospital, Ahvaz
Full name of responsible person
Saman Ketabchian
Street address
Khuzestan - Ahvaz - Golestan - Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 61 3320 4501
Email
ketabchian.s@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Armin Mohammadi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 61 3320 4501
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saman Ketabchian
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 61 3320 4501
Email
sketabchian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saman Ketabchian
Position
assistance of VASCULAR SERGERY
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 61 3320 4501
Email
ketabchian.s@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saman Ketabchian
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1111111111
Phone
+98 61 3320 4501
Email
sketabchian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be shareable
When the data will become available and for how long
6 months after publication
To whom data/document is available
Researchers working in academic centers
Under which criteria data/document could be used
If further analysis is required after submitting the request
From where data/document is obtainable
Director of Vascular Surgery Department, Golestan Hospital, Ahvaz
What processes are involved for a request to access data/document
Submit a request stating the reason and the amount of access required