Comparative study of the consequences of performing angiography and angioplasty of the lower limb in one stage by simultaneous Ipsilateral double puncture technique and in two-stage delayed technique in patients with chronic lower limb ischemia
Comparison of the consequences of performing angiography and angioplasty of the lower limb in one stage by simultaneous ipsilateral double puncture technique and in two-stage delayed technique in patients with chronic lower limb ischemia
Design
A randomized controlled trial with random allocation of 71 patients in each group,and followed for 1 month.
Settings and conduct
This study will be conducted on patients in Razi and Golsar hospitals. Patients will be divided into two equal groups of 71 people.The subjects will be divided into two blocks by random allocation method. For intervention group, an angiography and angioplasty will be performed simultaneously with two puncture in the femoral artery on the lesion side.In control group, these two diagnostic methods will be performed with a delay of at least 2 weeks. After angiography and angioplasty, patients will be admitted for 24 hours in both of these procedures, and then will be followed one week and one month later. The results and complications will be documented.
Participants/Inclusion and exclusion criteria
Inclusion criteria: chronic limb ischemia symptoms with pain during rest; unhealing wounds or gangrene .
Exclusion criteria: overweight; pregnancy;previous hypersensitivity to the contrast agent; renal failure, coagulopathy.
Intervention groups
In intervention group, an angiography and angioplasty will be performed simultaneously with two puncture in the femoral artery on the lesion side.
In control group, these two diagnostic methods will be performed with a delay of at least 2 weeks.
Main outcome variables
Angiographic and angioplastic complications such as; pseudo aneurysm ; retro peritoneal hematoma; embolism;embolism requiring surgery;
vessel rupture;perforation ;thrombosis;re-occlusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161026030508N3
Registration date:2018-06-24, 1397/04/03
Registration timing:registered_while_recruiting
Last update:2018-06-24, 1397/04/03
Update count:0
Registration date
2018-06-24, 1397/04/03
Registrant information
Name
Hosein Hemmati
Name of organization / entity
Vascular surgery and dialysis research center, Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 3354 2460
Email address
hemmati@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the consequences of performing angiography and angioplasty of the lower limb in one stage by simultaneous Ipsilateral double puncture technique and in two-stage delayed technique in patients with chronic lower limb ischemia
Public title
Comparative study of the consequences of performing angiography and angioplasty of the lower limb in one stage by simultaneous Ipsilateral double puncture technique and in two-stage delayed technique in patients with chronic lower limb ischemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of ILC symptoms
presence of pain during rest
Gangrene
Unhealing wound
Exclusion criteria:
Overweight
Pregnancy
Previous sensitivity to contrast agent
Renal failure
Coagulopathy
Noting have indication of angioplasty after angiography
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
142
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be divided into two blocks by random allocation method.In this study, patients will be divided into two equal groups of 71 people in each group.
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
Ethics committee of Guilan University of Medical Sciences
Street address
Razi Hospital, Sardar jangal street
City
Rasht
Province
Guilan
Postal code
4144895655
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.GUMS.REC.1397.048
Health conditions studied
1
Description of health condition studied
Chronic Limb Ischemia
ICD-10 code
I73.9
ICD-10 code description
Peripheral vascular disease, unspecified
Primary outcomes
1
Description
Complications of angiography and angioplasty
Timepoint
One week and one month after each method
Method of measurement
Researcher made questionnaire
2
Description
Consequences of angiography and angioplasty
Timepoint
One week and one month after each method
Method of measurement
Researcher made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: performing angiography and angioplasty simultaneously with two puncture in the femoral artery at the lesion side
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital in Rasht City
Full name of responsible person
Hossein Hemmati
Street address
Razi Hospital,SardarJangal Street
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Email
RDC@gums.ac.ir
2
Recruitment center
Name of recruitment center
Golsar Hospital in Rasht City
Full name of responsible person
Hossein Hemmati
Street address
Golsar Street,Golsar Hospital
City
Rasht
Province
Guilan
Postal code
001333113911
Email
RDC@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
ُShadman Nemati
Street address
17 Shahrivar St., Dept. of Research and Technology
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Hossein Hemmati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Razi Hospital,Sardar Jangal Street
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Email
RDC@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hossein Hemmati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular surgery
Street address
Sardar Jangal Street, Razi Hospital
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Email
RDC@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zakiyeh Jafaryparvar
Position
master science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sardar Jangal Street, Razi Hospital
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Email
jafaryparvar_zakiyeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available