Comparison between Cheatham-Platinum Stent and Self-Expandable Uncovered Nitinol Stent in patients with Coarctation of Aorta - A Randomized Controlled Trial
Comparison of two methods of stenting with Patients with Nitinol Uncovered Self-expandable Stent versus Cheatham Platinum Stent in patient with native coarctation of aorta
Design
Two parallel groups randomized trial with blinded outcome assessment
Settings and conduct
The trial will be held in a hospital setting (Rajaie Cardiovascular Medical and Research center) on patients with native coarctation of aorta . Patients will be randomized via central web based method into two interventional groups with two different stenting methods. Treating physician and patients will not be blinded. Stenting outcome after the procedure and 6 months later will be evaluated via echocardiography. Coarctoplasty complications will be evaluated via aortic CT-angiography after one year.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients with native coarctation of aorta who were referred to Rajaie cardiovascular medical and research center for coarctoplasty
Exclusion Criteria :
Patients with Non-circular aortic arch، patients with preductal coarctation of aorta، patients with hypoplastic Aortic Arch، patients with right aberrant subclavian artery، patients with stenosis more than 20 mm in length، patients with an aneurysm along with coarctation، patients with common femoral and external iliac artery less than 7 mm in diameters
Intervention groups
In this study there are two interventional groups:
First group: Patients with coarctation of aorta who underwent coarctoplasty with Nitinol Uncovered Self-expandable Stent, and the second group: patients with coarctation of aorta who underwent coarctoplasty with Cheatham Platinum Stent.
Main outcome variables
Stent migration, aortic perforation, success rate, access site complication, recoarctation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041406N3
Registration date:2019-04-20, 1398/01/31
Registration timing:registered_while_recruiting
Last update:2019-04-20, 1398/01/31
Update count:0
Registration date
2019-04-20, 1398/01/31
Registrant information
Name
Parham Sadeghipour
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2092
Email address
psadeghipour@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Cheatham-Platinum Stent and Self-Expandable Uncovered Nitinol Stent in patients with Coarctation of Aorta - A Randomized Controlled Trial
Public title
Stenting in Coarctation of Aorta (CoA)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with native Corctation of aorta referred to rajaie cardiovascular medical and research center for stenting
Exclusion criteria:
Patients with noncircular aortic arch
Patients with preductal coarctation
Patients with hypoplastic aortic arch
Patients with right aberrant subclavian artery
Patients with stenosis more than 20 mm in length
Patients having aneurysm along with coarctation
Patients with common femoral artery and external iliac artery less than 7 mm in diameter
Age
From 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed via permuted block randomization method. Allocation will be generated via a web based system and consequently concealment will be central using computer software. Unit of randomization will be individual patients and no stratification will be applied.
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
Rajaie Cardiovascular Medical and Research Center Ethic committee
Street address
Vali-Asr ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2016-10-01, 1395/07/10
Ethics committee reference number
9540
Health conditions studied
1
Description of health condition studied
Coarctation ofaorta
ICD-10 code
Q25.1
ICD-10 code description
Coarctation of aorta
Primary outcomes
1
Description
Stent migration
Timepoint
During the procedure
Method of measurement
Fluoroscopy
2
Description
Aortic perforation
Timepoint
During the procedure
Method of measurement
Angiography
3
Description
Procedural success rate
Timepoint
Just after the procedure
Method of measurement
Catheterization
4
Description
Access site complication
Timepoint
Just after the procedure
Method of measurement
CT angiography
5
Description
Recoarctation
Timepoint
6 and 12 months after the intervention
Method of measurement
Catheterization
Secondary outcomes
1
Description
mortality
Timepoint
During hospitalization
Method of measurement
Questionnaire
2
Description
Aneurysm formation
Timepoint
12 months after intervention
Method of measurement
CT angiography
Intervention groups
1
Description
Intervention group: Coarctoplasty with Self-Expandable Uncovered Nitinol stent
Category
Treatment - Devices
2
Description
Intervention group: Coarctoplasty with Cheatham-Platinum Stent
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie cardiovascular medical and research center
Full name of responsible person
Parham Sadeghipour
Street address
Vali-Asr ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Feridoun Nouhi
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2020
Email
fnoohi@rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie cardiovascular medical and research center
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
Rajaie cardiovascular medical and research center
Full name of responsible person
Parham Sadeghipour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Parham Sadeghipour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Parham Sadeghipour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@hotmail.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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available