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IRCT20181022041406N3 IRCT 2019-04-20 Rajaie cardiovascular medical and research center Stenting in Coarctation of Aorta (CoA) Comparison between Cheatham-Platinum Stent and Self-Expandable Uncovered Nitinol Stent in patients with Coarctation of Aorta - A Randomized​ Controlled Trial 2016-10-22 anticipated 100 Complete https://irct.ir/trial/35771 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Coarctation ofaorta. Intervention 1: Intervention group: Coarctoplasty with Self-Expandable Uncovered Nitinol stent. Intervention 2: Intervention group: Coarctoplasty with Cheatham-Platinum Stent. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Parham Sadeghipour
Vali-Asr Ave, Hashemi Rafsanjani Exp
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 2092 psadeghipour@hotmail.com Rajaie cardiovascular medical and research center scientific Parham Sadeghipour
Vali-Asr Ave, Hashemi Rafsanjani Exp
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 2092 psadeghipour@hotmail.com Rajaie cardiovascular medical and research center Iran (Islamic Republic of) All patients with native Corctation of aorta referred to rajaie cardiovascular medical and research center for stenting 16 years no limit Both 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 Q25.1 Coarctation of aorta Treatment - Devices Treatment - Devices Intervention group: Coarctoplasty with Self-Expandable Uncovered Nitinol stent Intervention group: Coarctoplasty with Cheatham-Platinum Stent Stent migration. Timepoint: During the procedure. Method of measurement: Fluoroscopy. Aortic perforation. Timepoint: During the procedure. Method of measurement: Angiography. Procedural success rate. Timepoint: Just after the procedure. Method of measurement: Catheterization. Access site complication. Timepoint: Just after the procedure. Method of measurement: CT angiography. Recoarctation. Timepoint: 6 and 12 months after the intervention. Method of measurement: Catheterization. Mortality. Timepoint: During hospitalization. Method of measurement: Questionnaire. Aneurysm formation. Timepoint: 12 months after intervention. Method of measurement: CT angiography. Rajaie cardiovascular medical and research center Approved 2016-10-01 Rajaie Cardiovascular Medical and Research Center Ethic committee Vali-Asr ave, Hashemi Rafsanjani Exp Tehran Tehran Iran (Islamic Republic of)