Comparison of effectiveness of drug coated balloon angioplasty versus plain balloon angioplasty in chronic lower extremity ischemia patients in Ahvaz Golestan Hospital
Design
Clinical trial with control group, parallel group randomized trial with random number table. Phase 4 of randomized clinical trial and probably the number of patients is 60 .
Settings and conduct
All eligible patients based on inclusion criteria will be recruited. Their ankle brachial index will be measured and CT angiography wil be done. After matching, they will be divided in to two groups of control and intervention. In control group plain balloon angioplasty and in intervention group drug coated balloon angioplasty will be performed. Patients will be followed for Rutherford class and ankle brachial index changes for 6 months.
Participants/Inclusion and exclusion criteria
patients in Rutherford class 3 to 6, length of arterial lesion less than 15 centimeters( TASC A,B), single new arterial lesion. Serum creatinine less than 1.5 milligram per deciliter. No history of hemorrhagic stroke in past 3 months.
Intervention groups
Intervention : drug coated balloon angioplasty in chronic lower extremity ischemia patients
Control : plain balloon angioplasty in chronic lower extremity ischemia patients
Main outcome variables
Ankle brachial index; Rutherford classification
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180520039745N1
Registration date:2019-05-27, 1398/03/06
Registration timing:prospective
Last update:2019-05-27, 1398/03/06
Update count:0
Registration date
2019-05-27, 1398/03/06
Registrant information
Name
Ahmad Sadegh pour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
sadeghpour.ahmad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of drug-coated balloon angioplasty versus plain balloon angioplasty in chronic lower extremity ischemia patients
Public title
drug-coated and plain balloon angioplasty in chronic lower extremity ischemia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
lower limb chronic ischemia ( Rutherford class 3-6)
Arterial lesion TASC A, B
Exclusion criteria:
previous surgery on femoral artery
severe arterial lesion calcification
sudden symptom onset
acute or subacute arterial occlusion or thrombus
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After matching according to Rutherford and TASC classification, randomization is done with random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Ahvaz University of Medical Science
Street address
Golestan Ave, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.AJUMS.REC.1397.849
Health conditions studied
1
Description of health condition studied
lower limb chronic ischemia
ICD-10 code
I70.2
ICD-10 code description
Atherosclerosis of native arteries of the extremities
Primary outcomes
1
Description
ankle brachial index change
Timepoint
measurement of ankle brachial index before, 10 days, 2 months and 6 months after intervention
Method of measurement
ankle brachial index device
2
Description
Change of Rutherford class
Timepoint
Evaluation of Rutherford class before, 10 days, 2 months and 6 months after intervention
Method of measurement
Rutherford classification scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: drug coated balloon angioplasty. According to inclusion criteria and after randomizing , patients in intervention group will undergo drug coated balloon angioplasty. Drug coated balloon is containing 2 micro gram per milliliter of Paclitoxcel with american brand of BARD.
Category
Treatment - Surgery
2
Description
Control group: plain balloon angioplasty. According to inclusion criteria and after randomizing , patients in control group will undergo plain balloon angioplasty.Plain balloons are american brand of BARD.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Iraj Nazari
Street address
Golestan Ave, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
golestanhospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badvi
Street address
Golestan Ave, Ahvaz University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Web page address
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
Ahmad Sadeghpour
Position
Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Vascular Surgery
Street address
Golestan Ave, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
dr.ahmadsadeghpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Sadegh pour
Position
fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Vascular surgery
Street address
Golestan Hospital, Golestan Ave.
City
Ahwaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Fax
Email
dr.ahmadsadeghpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Sadegh Pour
Position
fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Vascular surgery
Street address
Golestan Hospital, Golestan Ave.
City
Ahwaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Fax
Email
dr.ahmadsadeghpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data of main consequence is participle.
When the data will become available and for how long
Initiate of accessibility 6 months after printing of results.
To whom data/document is available
Data will be accessible only for academic and scientific researchers.
Under which criteria data/document could be used
Using of data for meta analysis is permissible.
From where data/document is obtainable
Ahmad Sadegh pour
Tel number: 989128092249
E.mail: dr.ahmadsadeghpour@gmail.com
What processes are involved for a request to access data/document
َAfter sending application to scientific responsible via call or E.mail, data files will be sent within a week.