Endovascular stenting with covered cp stent compared with bare cp stent for adult patients with coarctation: the initial and intermediate-term follow up results
Target of this study is comparing six months follow up between covered and bare cp stent in adult patients with coarctation . Thirty above 12 years of age patients with COA, will go under the stenting procedure by two interventionists. All the information will be recorded before and after the procedure. The patients will go under echocardiography after the stenting and the success of procedure is defined as a 20 mmHg decrease in gradient immediately after stenting and increase of aortic lumen. The patients will be flowed up in 1st, 3d and 6th months of stenting by clinical examinations and echocardiography to evaluate the location of stent and incidence of pseudoaneurysm. Also the patients will go under angiographic follow up 6 months after stenting with a multi-slice CT angiography, 64 (MSCT).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012045311N1
Registration date:2011-12-03, 1390/09/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-03, 1390/09/12
Registrant information
Name
Bahram Sohrabi
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2077
Email address
sohrabib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences and Health Services
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Endovascular stenting with covered cp stent compared with bare cp stent for adult patients with coarctation: the initial and intermediate-term follow up results
Public title
Comparison of short-term and intermediate-term outcomes between covered and bare cp stent in adult patients with coarctation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients above 12 years of age with accurate documented information diagnosed with post ductal COA and average gradient above 20 mmHg with or without hypertension candidates of stenting. Exclusion criteria: Patients with segmental coarctation; aortic arch hypoplasia; ductal coarctation blades.
Age
From 12 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences and Health Services
Street address
Golgasht St
City
Tabriz
Postal code
Approval date
2011-02-20, 1389/12/01
Ethics committee reference number
9626/4/5
Health conditions studied
1
Description of health condition studied
Aortic Coarectation
ICD-10 code
Q25.1
ICD-10 code description
Coarctation of aorta
Primary outcomes
1
Description
Recoarectation
Timepoint
3 months
Method of measurement
Echocardiography and Angiographic followup
Secondary outcomes
1
Description
Hypertension during follow-up
Timepoint
3 months
Method of measurement
physical exam
Intervention groups
1
Description
stenting of aortic coarection with bare stent
Category
Treatment - Surgery
2
Description
stenting of aortic coarection with coverd stent
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Babak Kazemi
Street address
Madani hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mohammadreza Baghaie
Position
Assistant, heart superspecialty
Other areas of specialty/work
Street address
Madani hospital
City
Tabriz
Postal code
Phone
+98 41 1337 0032
Fax
Email
Reza1932@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Bahram Sohrabi
Position
Interventional Cardiology Fellowship
Other areas of specialty/work
Street address
Tabriz Madani Hospital
City
Tabriz
Postal code
Phone
+98 41 1337 0032
Fax
Email
sohrabib@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)